September 23, 2011
By C. Elizabeth O'Keeffe*
Bioterror and Lessons Learned From 9/11
In the fall of 2001, the United States was confronted by two major public health challenges: the anthrax mailings and threat of a biological attack, and the subtler but ultimately more harmful plume of toxic dust that rose from Ground Zero. The country was prepared for neither.
In the months and years that followed, bioterror proved to be the easier threat to confront, or at least to spend money on. The plume's damage was harder to address, not least because government officials prematurely insisted on its safety. In both cases, one theme is universal: the wrong decisions were made, and lessons have been incompletely learned.
"I keep getting asked: are we safer today than on 9/11?" says Laurie Garrett, the Pulitzer Prize-winning author of I Heard the Sirens Scream, a new book on 9/11 and its public health aftermath. "My answer is that we've spent an enormous amount of money, but I'm not at all convinced that the expenses have made us safer." The author of The Coming Plague: Newly Emerging Diseases in a World Out of Balance and Betrayal of Trust: The Collapse of Global Public Health, Garrett lives in New York City, NY. On the morning of Sept. 11, 2001, she watched the horror from the Brooklyn banks of the East River. I Heard the Sirens Scream is both a diary of that fateful autumn and a journalistic investigation of what followed.
What we see, when you look at the lessons of 9/11, is that these people were burning candles at both ends. They were thoroughly exhausted. We demanded of our public health personnel a scale of performance that lasted for weeks. And one of the things that was really startling for me in the research to I Heard the Sirens Scream was how extremely strapped our public health people in New York City and Washington, DC were before the attack. Afterwards, our health departments, our forensics departments, were all on full alert. They didn't go off alert until well after Thanksgiving. Many were essentially running on fumes. I think they would say that a lot of decision-making suffered out of exhaustion.
Before 9/11, old-guard bioterror experts used the phrase dual-use to refer to difficulties in surveillance and verification: The same place that made pharmaceuticals could make biological weapons. But now the phrase gets used differently. People talk about bang for their buck. They say, "This expenditure is good for everyday health as well as this terrible thing that may happen one day." Dual-use now tends to justify stockpiling vaccines and purchasing technology. But I would say the appropriate use of the phrase is that the people you will rely on--to protect Americans, to solve great biological mysteries, to determine the appropriate responses--are the same people you rely on every single day to make sure the water coming from your tap is safe to drink, that the air around your building is safe to breathe, that the food you buy at your grocery store is safe from salmonella. Every aspect of American infrastructure, especially health, is genuinely capable of performing multiple functions and has to be funded accordingly and sustainably so. But we're seeing the opposite. Budgets are getting hacked right and left. Health departments are cutting right and left.
When public health is at its best, it's a local, community-based operation. The community knows who its public health officers are. Most public health departments are always looking for volunteers to go out and do education and teach kids about cavities and brushing their teeth. That's public health. It might not sound sexy, it might not have bells and whistles, but at a time when we're doing fiscal cutbacks on such a dramatic level, if the public doesn't step up then those functions don't get done.
Brandon Keim, How U.S. Learned the Wrong Health Lessons From 9/11, Wired Science (Sept. 9, 2011).
MedPAC Considers Options to Repeal SGR
On September 15, 2011, the Medicare Payment Advisory Commission (MedPAC) discussed four draft recommendations to address the Sustainable Growth Rate formula (SGR). In the past, the commission has recommended repealing the SGR but has not addressed specific alternatives to replace the payment formula nor how to pay for the cost of repeal, currently estimated to be $300 billion over ten years. A primary focus of the September discussion was reducing the cost of repeal and identifying other revenues to help pay for the repeal.
In his opening comments, Chairman Glenn Hackbarth, JD, stated that he personally felt a "growing sense of urgency" to address the SGR; that not addressing the SGR would leave a "destabilizing element" in Medicare. The SGR is a statutory formula that requires reductions to physician updates if physician spending in aggregate exceeds national targets. Since 2002, the formula has produced negative updates, although Congress typically passed temporary patches to prevent the cuts from being enacted. Without congressional action, physician services will decrease by 29.5% on January 1, 2012.
The first draft recommendation replaces the SGR formula with ten years of statutory updates. To protect access for beneficiaries, the conversion factor for primary care services by primary care practitioners would be frozen for the entire period. Primary care practitioners would be defined by specialty and the types of services provided. For all other services, the conversion factor would be decreased by 5.9% for the first three years and then frozen for the next seven years. Despite the decreases to the conversion factor, MedPAC staff assumes the total practitioner revenue would grow during the period due to increases in the number of Medicare beneficiaries and increases in the volume of services received by each beneficiary.
The conversion factor reductions lower the cost of repealing the SGR by approximately $100 billion (from $300 billion to $200 billion). MedPAC is still reviewing possible offsets for this cost, but estimates $50 billion in savings would come from implementing previous MedPAC recommendations and $185 billion from options suggested by other groups. MedPAC plans to release publicly the potential offsets the week of September 19, 2011.
Chairman Hackbarth noted that the draft recommendation would not necessarily be endorsed outside of a full SGR repeal. All commissioners support SGR repeal, although a few had concerns about the specific recommendation. A few commissioners acknowledged that the ten-year update plan does not address the basic flaws with the SGR in that it does not consider individual physician quality and efficiency. Some commissioners stated that while they support primary care protections, the proposal does not address the basic issues with primary care payment. Other commissioners expressed concern about the differential between primary and non-primary services without additional data to support that recommendation.
In addition to the SGR proposal, two draft recommendations focused on improving the accuracy of the physician fee schedule through better data collection and identifying overpriced services. The final recommendation would use financial incentives to encourage physicians and other health professionals to participate in accountable care organizations.
The commission plans to vote on the recommendations during its October meeting.
Transcript of Proceedings of Public Meeting, MedPac (Sept. 15, 2011).
In honor of this month's season premieres, ABC News rounds up the "healthiest" shows on television.
Healthy TV Winner: Hot In Cleveland, TV Land. Three witty women (stars Wendie Malick, Jane Leeves, and Valerie Bertinelli) adopt Cleveland as the heartland of self-acceptance to show that hot equals healthy. The eighty-nine-year-old spark plug that is Betty White adds to the high jinks.
Best Integration of Medical News: Grey's Anatomy, ABC. This hospital drama, starring Ellen Pompeo and Patrick Dempsey, has fearlessly tackled tough, topical health issues with intelligence and compassion, from Alzheimer's disease to post-traumatic stress, ever since the show's inception in 2005.
Most Sensitive Portrayal of Autism: Parenthood, NBC. Watching Adam and Kristina Braverman (Peter Krause and Monica Potter) come to terms with their son Max's special needs gave a heartfelt--and helpful--glimpse of families living with a loved one with a condition on the autism spectrum.
Prevention Healthy TV Winner: The Biggest Loser, NBC. This show is a phenomenon, driving contestants to get healthy and drop pounds so they can win $250,000. With the help of ex-BL trainer Jillian Michaels and host Alison Sweeney, these men and women touch viewers' hearts and minds as they reshape their bodies--and their lives.
Most Clever Healthy Lifestyle Clues: Rizzoli & Isles, TNT. Detective Rizzoli (Angie Harmon) may be a crime-fighting woman, but she never wastes an opportunity to slip health information into a sentence--chastising a colleague to switch to decaf coffee or owning up to her childhood as an overweight kid, for example.
Most Relevant Use of a Medical Breakthrough: Glee, FOX. This ensemble musical show (with Jane Lynch, Matthew Morrison, and Lea Michele) has a ton of heart, featuring a wheelchair-bound character as just one of the gang. When Artie (Kevin McHale) got outfitted with a robotic exoskeleton called ReWalk, which (in real life) allows paraplegics partial mobility, we all got lumps in our throats.
Best Integration of Green Living: Modern Family, ABC. Typical episodes include Mitchell (Jesse Tyler Ferguson) coming home from shopping for local produce at the farmers' market, his reusable market basket filled with kale, while the Dunphys (Julie Bowen and Ty Burrell) play a boys-versus-girls ball game for the right to pass on dishwashing duty.
Prevention Healthy TV Winner: Parks And Recreation, NBC. Amy Poehler heads a cast that's fun, funny, and quirky. When Chris (Rob Lowe) offers a guest some greens and purrs, "Try it, salad's good for you," you know greens have made it to the big time.
Best Window Into the Aging Guy's Soul: Men Of A Certain Age, TNT. Whether it's adjusting to reading glasses or coping with bigger-deal scares like cancer, Ray Romano and his band of buds give women a secret decoder ring to men's mental and physical health concerns.
Most Daring Concept: The Big C, Showtime. Skin cancer takes center stage as actress Laura Linney's Cathy lives a full life, despite her diagnosis.
Tie! Dancing With The Stars (DWTS), ABC, and SYTYCD, FOX. On DWTS (hosted by Brooke Burke and Tom Bergeron), stars like Kirstie Alley have made dancing for weight loss simply inspiring. And SYTYCD has given us congressionally endorsed National Dance Day, which promotes an active lifestyle.
Bari Nan Cohen, TV Shows That Make You Healthier, ABC News Health (Sept. 10, 2011).
Completion of Presidential Bioethics Commission Report on 1940 Guatemala Experiments
On August 29, 2011, a presidential bioethics commission announced the completion of an investigation into 1940s experiments in Guatemala on sexually transmitted diseases (STDs), which involved the infection of around 1,500 people (mostly prostitutes, prisoners, and mental hospital patients) with the STDs without their consent. They found, among other things, that some of the researchers who partook in the Guatemalan study had also been involved in a similar, earlier study in Indiana, where prison inmates were intentionally infected with gonorrhea--albeit with their consent.
The unethical experiments were originally brought to light in the fall of 2010 by Wellesley College historian Susan Reverby as she was looking into archived documents on the Tuskegee syphilis study--a study carried out by the U.S. Public Health Service that followed the course of untreated syphilis in black males in Alabama for forty years. After Reverby discovered evidence that the U.S. government had conducted similar experiments on STDs in vulnerable populations in Guatemala, President Barack Obama issued a formal apology to the Guatemalan government and asked a bioethics commission to both further investigate the matter and reassess current regulations concerning research involving human subjects.
"It is important that we accurately document this clearly unethical historical injustice," University of Pennsylvania President Amy Gutmann, who chairs the presidential bioethics commission, said in a press release. "We do this to honor the victims."
C. Luiggi, Lessons From Past Unethical Experiments, The Scientist (Aug. 30, 2011).
Healthcare Fraud Prosecutions Reach New High
Federal prosecutions for healthcare fraud are skyrocketing, on track to rise by 85% by the end of the year, according to a report. In the first eight months of 2011, the government launched 903 healthcare fraud prosecutions, according to an analysis of U.S. Deptartment of Justice data by the Transactional Records Access Clearinghouse (TRAC), a data-gathering and research organization at Syracuse University. In 2010, the number of healthcare fraud prosecutions totaled 731. The high number stems from a series of large-scale investigations by the Federal Bureau of Investigation and the Healthcare Fraud Prevention and Enforcement Action Team. In Puerto Rico alone, 420 people were charged with healthcare fraud in 2011, TRAC research shows. Among the fifty states, Florida led the nation in fraud activity, accounting for one out of every nine healthcare fraud prosecutions. David Burnham, TRAC's co-director, said it appears the government is making special efforts to combat healthcare fraud. Here are several of the government's recent efforts:
In August, a U.S. Government Accountability Office report showed that the Centers for Medicare & Medicaid Services expanded its anti-fraud efforts after receiving increased funding from Congress and reallocating money saved from Medicare contractor consolidations since 2006. The operations include more oversight of Medicare private insurers and drug plans.
In February, the U.S. Deptartment of Health and Human Services, Office of Inspector General (HHS) launched a ten most-wanted list featuring the nation's worst offenders to draw attention to the faces behind healthcare fraud crimes. The list is derived from a pool of more than 170 people accused of healthcare fraud and includes mug shots, identification information, and criminal profiles.
In January, HHS outlined renewed strategies aimed at combating fraud under the healthcare system reform law. Those steps include tougher screenings of healthcare professionals who are planning to participate in Medicaid or Medicare, increased penalties for defendants, and the withholding of payments to recipients under investigation.
Meanwhile, federal agents in late August and early September charged ninety-one healthcare professionals, including eleven doctors, with filing $295 million in false medical claims during a nationwide Medicare Fraud Strike Force operation. In one case, a federal grand jury returned indictments against thirteen people operating and working for the Biscayne Milieu Health Center in Miami. They were charged with conspiring to submit false claims for Medicare services that were medically unnecessary or never provided. The mental health center offered kickbacks to brokers who recruited patients for partial hospital program services, federal officials said. Some patients allegedly were told they would be evicted from boardinghouses if they did not attend therapy programs.
Alicia Gallegos, Healthcare Fraud Prosecutions Reach New High, Am. Med. News (Sept. 19, 2011).
Commercial Support Down for CME
Drugmakers' and device makers' financial support for continuing medical education fell for the third straight year in 2010, reaching its lowest level since 2002. With industry support falling to $830 million--31% lower than the high-water mark of $1.2 billion in 2007--continuing medical education (CME) providers are relying more heavily on the fees they charge physicians. Those fees are $20-$50 per credit hour. Annual CME requirements range from fifteen to fifty credit hours, depending on the state. Payments from doctors, hospitals, medical schools, and other sources rose 9% from 2009 to 2010 and now account for more than half of accredited CME providers' revenue. Commercial support made up 37% of the $2.2 billion in 2010 CME funding, down from 47% in 2007, according to data released in August by the Accreditation Council for Continuing Medical Education. Industry funding's decline came as total CME revenue rose 3% in 2010. "The balance of revenue has shifted, with commercial support income decreasing and other income increasing," the Accreditation Council for Continuing Medical education (ACCME) said.
The slumping economy, a sluggish pharmaceutical pipeline, tighter ACCME rules, and growing criticism of industry-funded CME are responsible for the drop in commercial support, experts say. "Some of the restrictions and the criticism have caused money to leave the marketplace," said Thomas Sullivan, president of the for-profit Rockpointe Corp., a Columbia, MD-based medical education company that serves about 40,000 physicians and healthcare professionals annually. "Big [pharmaceutical] companies don't like to get criticized." Industry funding of for-profit medical education and communications companies has come under extra scrutiny. Critics argue that these firms, which rely heavily on commercial funding, are likelier than medical schools and physician organizations to let bias slip into their educational offerings. In 2008, Pfizer Inc., the world's top-selling drugmaker, announced it no longer would send grant money to medical education companies, and number two seller GlaxoSmithKline followed suit in 2009. Commercial support for CME companies has fallen by more than half since 2007. That year, the ACCME strengthened its commercial-support rules, barring medical industry firms from jointly sponsoring CME or offering guidance on how activities should be structured.
While the decline in commercial support has not been as steep at medical schools, the leading providers of CME, some schools are turning away from industry funding. In January, the University of Michigan Medical School enacted a plan to give up commercial support, which had accounted for 45% of its $1.2 million annual CME budget. The University of Wisconsin School (UW) of Medicine and Public Health is taking a more gradual approach. "Commercial support has dropped precipitously. At the high point, it was around $9 million, and now we're down to $2 million," said George Mejicano, MD, the school's associate dean for continuing professional development. "We made a policy decision to try to wean ourselves away from commercial support, and we have a strategic goal of further diversifying by 2015." In 2006, about 80% of UW's proposals for CME grants from industry won approval. Now, less than 30% get the green light, said Mejicano, who also serves as president of the Alliance for Continuing Medical Education, a trade group that represents 2,300 members working in the healthcare-related continuing education field. That kind of uncertainty has encouraged the school to seek financial support for CME from health plans, healthcare systems, and others, while raising physician fees slightly.
While nine in ten physicians and other healthcare professionals say industry funding raises the risk of biased CME, only 42% are willing to pay higher registration fees to eliminate commercial support, according to a May 9, 2011, Archives of Internal Medicine study. Even so, it appears that the criticism of industry funding is making headway, said Jeffrey Tabas, MD, the study's lead author. "The consistent but gradual drop in commercial funding may be due to increased CME provider and physician consumer awareness of the pitfalls of commercial funding," said Tabas, who serves on the governing board of the University of California, San Francisco, School of Medicine's Office of Continuing Medical Education. "Hopefully, this represents a weeding out of undesirable commercial support. We will need to see if the checks and balances that are currently in place are ultimately considered adequate to control bias and influence."
In June, the American Medical Association (AMA) adopted ethics policy saying that industry funding of CME should be avoided when possible. The AMA Council on Ethical and Judicial Affairs opinion says preference should be given to CME faculty with no financial interests in the subject matter. The policy is likely to speed the turn away from commercial support, said Daniel Carlat, MD, a prominent critic of industry-funded CME. "The bottom line is that we are in the midst of an overdue correction in the funding structure for CME. Doctors are once again taking over funding for their own education," said Dr. Carlat, a psychiatrist in Newburyport, MA. "I predict we'll see 5% drops in commercial support in both 2011 and 2012--with most of that coming at the expense of for-profit medical-education companies." Carlat operates Carlat Publishing, an accredited CME provider that accepts no money from industry. Despite such predictions, change is not happening fast enough, said Adriane Fugh-Berman, MD, who directs PharmedOut, a project at Georgetown University in Washington that advocates steering clear of pharma-funded CME. "Much of CME is still funded by industry--$830 million is still far from zero, which is what it should be," she said. "There's no such thing as unbiased, industry-funded continuing medical education."
Kevin B. O'Reilly, As CME Funding Shifts From Industry, Others Foot The Bill, Am. Med. News (Sept. 12, 2011).
"Obamacare" Phase II?
In healthcare programs, President Barack Obama is recommending a series of reforms that builds on the reforms in the Affordable Care Act to strengthen Medicare and Medicaid. It is his belief that these proposals will save $248 billion in Medicare and $72 billion in Medicaid and other health programs over ten years, and extend the life of the Medicare Trust Fund by three years. This is accomplished in a way that "does not shift risks unfairly onto the individuals they serve; slash benefits; or undermine the fundamental compact they represent to our Nation's seniors, people with disabilities, and low-income families. Any savings that affect beneficiaries do not begin until 2017 and do not affect middle-income and current beneficiaries. Other health and Medicaid savings amount to $72 billion, and because of the structural nature of these reforms to both programs, health savings grow to over $1 trillion in the second decade." Moreover, President Obama will veto any bill that "takes one dime from the Medicare benefits seniors rely on without asking the wealthiest Americans and biggest corporations to pay their fair share."
J. Lew, The President's Plan for Economic Growth and Deficit Reduction, The White House Blog (Sept. 19, 2011).
CMS Issues Final Rule for Medicaid RACs
In February, the Centers for Medicare & Medicaid Services (CMS) delayed its expected April 1, 2011, implementation of the Medicaid recovery audit contractors (RACs) final rule until an unspecified time later this year. That unspecified date became Wednesday, September 22, 2011.
The new initiative, modeled after the Medicare RAC program, aims to fight waste and fraud in Medicaid and will save taxpayers an estimated
$2.1 billion over the next five years, according to a press release from the U.S. Department of Health and Human Services (HHS). About
$900 million will be returned to states.
"Today we are building on an already successful program that targets improper payments in our healthcare programs and recovers those dollars, making Medicare and Medicaid more reliable and responsible," HHS Secretary Kathleen Sebelius said in the press release. "We simply can't afford to see even one penny of our healthcare dollars wasted and expanding this program will help us reach that goal."
The rule itself implements Section 6411 of the Affordable Care Act and provides guidance to individual states related to federal/state funding of state start-up, operation, and maintenance costs of Medicaid RACs, and the payment methodology for state payments to Medicaid RACs, according to the rule.
James Carroll, CMS Releases Medicaid RACs Final Rule, HealthLeaders Media (Sept. 15, 2011).
CDC Issues New Guidelines to Reduce Organ Infections
More thorough donor screening and more advanced organ testing to help protect transplant patients from infectious diseases are recommended in a draft of an updated organ transplant guideline released Wednesday by the Centers for Disease Control and Prevention (CDC).
The goal of the new guideline is to reduce infections such as HIV (the virus that causes AIDS), hepatitis B virus (HBV), and hepatitis C virus (HCV). Screening is already done for HIV, but HBV and HCV should be added to the screening process, CDC said.
From 2007-2010, CDC was involved in more than 200 investigations of suspected, unexpected transmission of HIV, Hepatitis B, and Hepatitis C through transplants. In some of the confirmed cases, the transplant recipient died due to the infection.
The existing guideline was created in 1994. Other major proposed changes to the guideline include updated and more sensitive tests for donor organs, and a revised set of donor risk factors that can help doctors get a better idea of possible problems with donors' organs.
The new draft guideline focuses on organ safety because the U.S. Food and Drug Administration has already implemented tighter regulations for tissue and semen donors.
"Our first priority must be patient safety. These recommendations will save lives and reduce unintended disease in organ recipients," Dr. Matthew J. Kuehnert, director of CDC's Office of Blood, Organ, and Other Tissue Safety Office, said in a CDC news release. "The guideline will help patients and their doctors have information they need to fully weigh risks and benefits of transplanting a particular organ."
Robert Preidt, CDC Moves to Make Organ Transplantation Safer, Medline Plus (Sept. 21, 2011).
Could "Contagion" Event Really Happen?
Dr. Sanjay Gupta did not have to stretch much to portray a journalist who asks some tough questions in the new film "Contagion." "One of the big medical, ethical dilemmas is [when] you know a piece of information that is confidential. If you release it, it could cause panic and harm--but not releasing it could put your own family in danger--what do you do?" Gupta said. "That was sort of the moral quandary that [the movie] faced. We ended up talking a lot about that."
"I think people will have a sense of discomfort in some sense watching this," Gupta said. "The balance here is that there is a lot of science in this movie and it will be interesting to see how audiences respond to it."
S. Gupta, Could "Contagion" Event Really Happen?, CNN.com (Sep. 16, 2011).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.
*We would like to thank C. Elizabeth O'Keeffe, Esquire (University of Mississippi Medical Center, Jackson, MS), for providing this week's update.