Spotlight: A Win That's A Loss
The Supreme Court yesterday rejected an appeal by the tobacco industry to reconsider a 2006 district court verdict that found several leading cigarette companies broke anti-racketeering laws and deceived the public for nearly 50 years about the dangers of smoking. Although the high court's decision favored the Department of Justice, which originally filed the suit, the ruling means the Obama administration cannot seek to recoup up to $280 billion in tobacco industry profits or obtain $14 billion from the companies for a national anti-smoking campaign. The high court had previously denied a DOJ appeal on the issue. In the administration's appeal to the Supreme Court to reconsider the ruling, the Department of Justice said that the money corresponds with the amount of damage the industry has caused. (more)

Quote of the Day:
"The evidence now seems to be overwhelming that taking Avandia significantly increases a patient's risk of a heart attack, [which] will make it even more difficult for the FDA to justify keeping this dangerous drug on the market."
 
Rep. Rosa DeLauro (D-Conn.), reacting to a pair of studies released yesterday that further confirmed that GlaxoSmithKline's type 2 diabetes treatment Avandia increases patients' risk for heart problems and stroke





POLITICS & POLICY

CMS: Proposed Rule Could Impose Additional 6.1% in Cuts to Physician Medicare Reimbursement Rates
A proposed rule from CMS includes a provision that could impose an additional 6.1% reduction to Medicare's physician reimbursement rates beginning in 2011, HealthLeaders Media reports (Simmons, HealthLeaders Media, 6/28).

Physicians recently faced a 21.3% cut to Medicare reimbursement rates, but a bill (HR 3962) signed by President Obama on Friday delays that cut through November. The measure, which is fully offset with two revenue-raising provisions, also provides a 2.2% Medicare payment increase to physicians through November (American Health Line, 6/28). Unless Congress alters the sustainable growth rate formula or acts to avert the cuts, physicians essentially would face a 23.5% reduction in Medicare payments beginning in December.

According to HealthLeaders Media, the 6.1% reduction would be in addition to those scheduled reductions.

The proposed rule, which includes provisions related to the implementation of health reform, is open to comment until Aug. 24. CMS is expected to issue a final rule by Nov. 1. The proposed rule also would:

  • Eliminate out-of-pocket costs for preventive services for Medicare beneficiaries by waiving the Medicare Part B deductible and 20% coinsurance normally applied to such services beginning in 2011;

  • Define elements of care that must be included in a consultation for it to be classified as a wellness visit;

  • Define primary care services and outline incentive payments to primary care providers;

  • Offer incentives for physicians who perform major surgical procedures in areas with few health professionals;

  • Allow physician assistants to order post-hospital extended care services for beneficiaries;

  • Require physicians whose offices perform certain imaging services to provide patients with a list of other facilities that offer the same services; and

  • Increase review of misvalued codes under the physician fee schedule (HealthLeaders Media, 6/28).
-- compiled by Zach Swiss


'DOC FIX': Hospitals Express Questions, Concerns Over New 72-Hour Rule
Hospitals are seeking guidance from CMS regarding a recently enacted provision governing the first 72 hours of a patient admission, saying the measure will strain facility resources and reduce Medicare payments by more than $4 billion across a decade, CQ HealthBeat reports (Reichard, CQ HealthBeat, 6/28).

The provision is part of the stand-alone "doc fix" legislation President Obama signed into law on June 25 that will delay through November a 21% cut to physicians' Medicare reimbursements. Under the legislation, hospitals will receive a single bundled payment for all outpatient services provided within the first three days of an inpatient admission, thereby preventing facilities from billing "retrospectively," according to AHA News Now (AHA News Now, 6/28).

Prior to the new law, hospitals were able to bill separately for diagnostic services and non-diagnostic services related to the inpatient stay provided within three days of admission. To bill for these related services, hospitals had to exactly match diagnosis codes between inpatient admission and outpatient therapeutic services, which created confusion among facilities that "struggled to correctly apply" the rule to their billing operations, according to HealthLeaders Media.

The new law attempts to eliminate this confusion by adopting a new definition for these related services. Specifically, the new measure will bar hospitals from billing separately and will require that facilities bill all non-diagnostic services provided on the day of admission, as well as those in the three days before admission, as part of the inpatient stay. However, hospitals can bill separately if they demonstrate that non-diagnostic services are "unrelated to the admission," HealthLeaders Media notes. The provision is effective for services provided on or after June 25.

Hospitals say the new measure will present an administrative burden and require facilities to review each service provided during the three-day window to ensure billing is correct (Iarrobino/Carroll, HealthLeaders Media, 6/28). Hospitals also contend that the provision will slash payments by more than $4 billion across a decade, which adds to the billions of dollars in reductions they agreed to sustain in exchange for their support of the health care reform legislation (CQ HealthBeat, 6/28). There also are other unanswered questions stemming from the new measure, such as how the law will affect the RAC program and billing for services rendered prior to June 25 (HealthLeaders Media, 6/28).

CMS announced that it soon will clarify the new rule and issue recommendations for hospital billing under the new 72-hour provision. Until the agency provides guidance, CMS instructs hospitals to "include charges for all diagnostic and all non-diagnostic services that it believes" meet the requirements of this provision (HFMA, 6/28).

-- compiled by Audrey Horn

IN THE COURTS

TOBACCO: Supreme Court Rejects Industry Appeal on 2006 District Court Ruling
The Supreme Court on Monday rejected an appeal by the tobacco industry to reconsider a 2006 district court verdict that found several leading cigarette companies broke anti-racketeering laws and deceived the public for nearly 50 years about the dangers of smoking, the New York Times reports (Wilson, New York Times, 6/28).

In August 2006, U.S. District Judge Gladys Kessler concluded that the tobacco companies "lied, misrepresented, and deceived the American public, including smokers and young people ... about the devastating health effects of smoking," and "they distorted the truth about low tar and light cigarettes so as to discourage smokers from quitting" (American Health Line, 8/18/06).

Although the high court's decision favored the Department of Justice, which originally filed the suit, the ruling means the Obama administration cannot seek to recoup up to $280 billion in tobacco industry profits or obtain $14 billion from the companies for a national anti-smoking campaign. The Supreme Court had previously denied a DOJ appeal on the issue (Markon, Washington Post, 6/28). In the administration's appeal to the Supreme Court to reconsider the ruling, the Department of Justice said that the money corresponds with the amount of damage the industry has caused (American Health Line, 2/23).

The case now returns to the district court, where Kessler is expected to act on other aspects of the case, such as requiring the tobacco companies to run corrective advertising (New York Times, 6/28).

-- compiled by Santosh Rao

REGULATORY NEWS

PUBLIC HEALTH: FDA Issues Draft Guidelines on Antibiotic Use in Animals
FDA on Monday issued draft guidelines recommending that farmers administer antibiotics to food-producing animals only when necessary to preserve their health, the Washington Post reports. FDA officials said that extensive antibiotic use in animals, such as cattle, poultry and hogs, has contributed to a rising incidence of antibiotic-resistant bacteria strains in humans.

U.S. farmers administer antibiotics to animals -- often through drinking water -- to promote growth, treat illness and prevent infection. The Union of Concerned Scientists has estimated that nearly 70% of antibiotics used in the U.S. are given to animals.

Meanwhile, public health experts recently have cited an significant increase in the prevalence of antibiotic-resistant bacteria, which can cause severe and terminal illness in humans (Layton, Washington Post, 6/29). About 100,000 U.S. residents die annually from hospital-acquired, antibiotic-resistant illnesses, the New York Times reports. However, the number of deaths linked to agricultural uses of antibiotics is unknown (Harris, New York Times, 6/28).

Although FDA officials called antibiotic-resistant bacteria an "urgent" public health issue, farming groups urged the agency to provide more evidence to support its recommendations. Public health groups acknowledged FDA efforts to address the issue but said it is unlikely that farmers would follow the policy voluntarily because of potential financial risks (Washington Post, 6/29). Noting that the guidance is "nonbinding," FDA Principal Deputy Commissioner Joshua Sharfstein said the guidance was meant to "establis[h] a principle" and that the agency would consider increasing oversight and enacting further regulations, if necessary, CQ Today reports.
Lawmakers Attempting To Address Issue
Several lawmakers also are attempting to address antibiotic use in animals, CQ Today reports. Rep. Louise Slaughter (D-N.Y.) sponsored a bill (HR 1549) to restrict antibiotic use in animals, but the legislation is stalled in the House. The House Energy and Commerce Committee also has convened hearings on the issue, while Rep. Frank Pallone Jr. (D-N.J.), chair of the Health Subcommittee, said he intends to hold a hearing in July to examine the link between antibiotic use in animals and the development of antibiotic-resistant bacteria in humans (Ferguson, CQ Today, 6/28).

-- compiled by Cassandra Blohowiak


AVANDIA: New Studies Affirm Drug's Risk Ahead of FDA Hearing
Two studies released Monday provide new evidence that GlaxoSmithKline's type 2 diabetes treatment Avandia increases patients' risk for heart problems and stroke, the release of which comes two weeks before an FDA panel is scheduled to convene to determine whether Avandia should be pulled from the market, the Washington Post reports (Stein, Washington Post, 6/28).

Avandia has come under increased scrutiny since May 2007, when the Cleveland Clinic's Steven Nissen released an analysis that found the drug increased the risk of heart attack by 43% (Harris, New York Times, 6/28). Meanwhile, concerns about liability claims have increased since February, when a highly critical report on Avandia was published by Senate Finance Committee Chair Max Baucus (D-Mont.) and ranking member Chuck Grassley (R-Iowa) (American Health Line, 6/21).
Study Findings
The first study -- published in the Journal of the American Medical Association -- analyzed records of 227,571 Medicare beneficiaries who received either Avandia or Takeda's Actos. It found that Avandia patients had an increased risk of heart failure, stroke and death compared with patients who took Actos, suggesting that more than 47,000 Avandia patients between 1999 and 2009 suffered preventable ailments.

The second study -- published in the Archives of Internal Medicine -- was a follow-up analysis to Nissen's 2007 study, which examined additional information for more patients from multiple trials. It found that Avandia increased a patient's heart attack risk by 39% and the risk of heart-related death by 46% (New York Times, 6/28).
FDA Hearing
FDA at its hearing next month is expected to discuss the latest safety data regarding Avandia and solicit guidance from scientists about its market status, the AP/Detroit Free Press reports (Tanner, AP/Detroit Free Press, 6/28). Researchers and drug-safety advocates have said the pair of new studies should prompt FDA to remove Avandia from the market. However, GSK in a statement defended its drug, saying that taken together with previous studies, "these trials show that Avandia does not increase the overall risk of heart attack, stroke or death" (Washington Post, 6/28).
Lawmakers Get Involved
Grassley and Rep. Rosa DeLauro (D-Conn.) on Monday urged FDA to remove Avandia from the market, The Hill's "Healthwatch" reports. According to DeLauro, "The evidence now seems to be overwhelming that taking Avandia significantly increases a patient's risk of a heart attack," which "will make it even more difficult for the FDA to justify keeping this dangerous drug on the market." Grassley added, "The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July" (Pecquet, "Healthwatch," The Hill, 6/28).

-- compiled by Cassandra Blohowiak


DISEASE 'SLEUTHING': CDC Opens Joint U.S.-China Epidemiology Center in Shanghai
U.S. and Chinese federal health authorities on Tuesday officially opened a joint epidemiology research center in Shanghai intended to train experts on "sleuthing out" strategies to prevent chronic and epidemic disease outbreaks, the AP/Los Angeles Times reports. CDC Deputy Director Stephen Thacker said the agency is providing training and technical assistance at the new center, which will be "driven by what are the major public health issues" in China.

In recent years, China and other developing countries have faced serious outbreaks of deadly diseases, such as sudden acute respiratory syndrome and the bird flu in 2003 and the H1N1 influenza in 2009, particularly because they lack the proper infrastructure to deal with the outbreaks, the AP/Times reports.

Thacker said that countries like China need more experts in broad areas of public health and disease prevention, and not just communicable diseases. Wang Longxing, director of Shanghai's Health Bureau, acknowledged that the Chinese government is beginning to invest in more prevention initiatives. Thacker said that CDC in the past 30 years has trained more than 3,000 international epidemiologists (Kurtenbach, AP/Los Angeles Times, 6/29).

-- compiled by Santosh Rao

TRENDS & TIMELINES

OVERTREATMENT: 90% of Physicians Surveyed Say They Order Unnecessary Tests to Avoid Malpractice Lawsuits
More than nine of 10 U.S. physicians said doctors overtest and overtreat in order to shield themselves from malpractice lawsuits, according to a survey published Monday in the Archives of Internal Medicine, the AP/Chicago Tribune reports. The findings coincide with a recent Associated Press story reporting that many emergency department physicians overtreat in order to avoid lawsuits.

The survey -- funded by a grant from the Robert Wood Johnson Foundation -- of 1,231 U.S. physicians included ED physicians and other specialists, surgeons and primary care doctors. Physicians were asked two questions: "Do physicians order more tests and procedures than patients need to protect themselves from malpractice suits?" and "Are protections against unwarranted malpractice lawsuits needed to decrease the unnecessary use of diagnostic tests?"

According to the survey, 91% of physicians overall agreed with both statements. Ninety-three percent of male physicians and 87% of female physicians agreed that physicians overtest to avoid malpractice, and both genders responded equally that protections are necessary to reduce overtreatment. Survey co-author Tara Bishop, an internist at Mount Sinai School of Medicine, noted that "defensive medicine" likely costs the U.S. health care system billions of dollars annually and that many physicians can still be sued even if they follow guidelines for typical standards of care (Tanner, AP/Chicago Tribune, 6/28).
U.S. Residents Overtreated Until Death
In related news, many U.S. residents are treated in hospitals until death in order to try treatments that only keep them alive for a few more weeks, the AP/Tribune reports. According to the AP/Tribune, the tactic increases U.S. health care costs. For example, treating chronic illness in the last two years of life takes up almost one-third of Medicare spending.

Recent Dartmouth Atlas Project findings show that the average time that U.S. residents spend in hospice and palliative care once an illness has proved incurable is decreasing. However, hospitalizations during the last six months of someone's life are increasing, from 1,302 per 1,000 Medicare enrollees in 1996 to 1,441 in 2005, according to the project (Marchione, AP/Chicago Tribune, 6/28).

-- compiled by Matthew Wayt


SMOKE-FREE LEARNING: Universities Ban Tobacco on Campus
Colleges and universities are increasingly enacting campuswide tobacco-free policies in the latest example of nationwide efforts to combat smoking, CongressDaily reports. As of April, 395 colleges and universities have implemented smoke-free policies, up from approximately 60 in 2007.

Illinois, New Jersey and Wisconsin ban smoking in university housing, while smoking is prohibited on all college campuses in Iowa and Arkansas. Several other institutions, including the University of Florida and Pennsylvania-based Widener University, intend to enact such policies this fall, while all three University of Michigan campuses will ban smoking by 2011.

According to Katie Dunker -- a member of the Alcohol, Tobacco and Other Drugs Coalition of the American College Health Association and assistant director for health promotions at the University of Denver -- state clean air laws sparked interest in smoke-free policies among colleges and universities. In addition, Michael McNeil, health services director at Columbia University and former coalition chair, noted that more knowledge of secondhand smoke's health effects and increased awareness of cigarettes' environmental impact also could have encouraged colleges and universities to adopt smoke-free policies (Amisano, CongressDaily, 6/28).

-- compiled by Cassandra Blohowiak

ACCESS, QUALITY & COST

COST SHARE: Workers in Certain Industries Pay More for Health Care
Workers in certain industries accumulate more of the annual share of health costs with in-network co-payments than employees in other industries, according to a new report from health consultant HighRoads, HealthLeaders Media reports. The difference "points to an increasing volatility in plan designs for those industries pushing a greater share of cost to their employees and families," according to Josh Miley, principal of HighRoads.

The report -- which focused only on employer-based plans -- found that 79% of transportation industry workers and 69% of financial services workers pay $25 or more for office visits, while 97% of wholesale employees, 87% of service workers and 67% of manufacturing employees pay $20. In addition, it found that there is a significant difference in co-pays paid by health plan enrollees across different regions.

The report found that in 2010 monthly premiums for fully insured plans average $380 for single workers, $788 for an employee plus one, $726 for a worker plus children and $1,113 for a family. In addition, the report found that office visit co-pays across all fully insured plans have a median cost of $20, while specialist office visits have a median cost of $30. Inpatient hospitals have a median co-pay of $250, while emergency room co-pay is $75 and infertility treatment requires cost-sharing of 50%, according to the study (Clark, HealthLeaders Media, 6/25).

-- compiled by Matthew Wayt

ODDS & ENDS

YESTERDAY ON THE BLOG: The Blog Line
Below is a featured entry from American Health Line's blog, AHLAlerts.

After several months of political wrangling in the House and Senate, President Obama on Friday signed into law legislation (HR 3962) that puts a temporary hold on a 21% cut to physicians' Medicare reimbursements through the end of November.

Despite being its prime beneficiaries, physicians have had a rather lukewarm response to the "doc fix," which is the latest piece of legislation to delay cuts called for under Medicare's sustainable growth rate (SGR) formula. Analysts also are skeptical, and House Democrats only grudgingly voted for the bill. Most responses share a key concern: that the six-month doc fix merely kicks the can down the road.

  • Guest blogger Mandy Krauthamer Cohen -- executive director of Doctors for America -- writes at "The Wonk Room" that the "constant uncertainty about Medicare payment ... also engenders cynicism of government among physicians." Krauthamer Cohen expresses relief, noting the movement for a permanent fix for the SGR has an ally in President Obama when he said recently, "I believe we need to permanently reform the Medicare formula in a way that attacks our fiscal problems without punishing our hard-working doctors or endangering the benefits on which so many of our seniors rely." She continues, "Good stuff -- but it's time to turn those supportive statements into action" for "a more permanent payment solution" because "this issue is too complex, expensive and laden with pitfalls."

  • On the other side of the political spectrum, John Graham at the "Health Policy Blog" directs his criticism toward Republicans, who have been long proponents for a permanent SGR fix. Graham asks, "What do Republicans think they have achieved by pretending that they have 'fixed' the fee-schedule?" He writes that "by continuing to share 'joint-ownership' of unreformed Medicare with Democrats, Republicans lose (once again) an opportunity to differentiate themselves on health reform between now and November." He writes that "when [Senate Majority Leader] Reid gave up on the bigger bill Thursday evening, and [House] Speaker Pelosi brought the 'doc fix' to the House floor, the House Republicans could at least have not voted on the darned thing."
While the SGR-Medicare payments issue has been temporarily resolved, the larger "extenders" bill (HR 4213) -- of which it was a part, and includes a federal Medicaid assistance package -- remains in the Senate. On Thursday, Democrats failed to overcome a GOP-led-filibuster to end debate on the package. They needed 60 votes to advance the bill to the final votes but they came up three votes short. Fifty-seven of the 59-member Democratic caucus voted for cloture, with two senators sitting out the vote.

Over the weekend we learned that one of those senators -- 92-year-old Sen. Robert Byrd (W.Va.) -- had been ill and had later entered a hospital, where his condition gradually deteriorated. Noting his age and history of illness, bloggers naturally wondered about a vacant seat in the Democratic caucus and the Senate, where crucial legislation is still pending. (Editor's note: Byrd passed away early yesterday morning, and no official announcements have been made about the now-vacant Senate seat.)

  • On Saturday, Nate Silver of FiveThirtyEight.com noted that Byrd's term was set to expire on Jan. 3, 2013 and that under "West Virginia state law on handling Senate vacancies, 'if the vacancy occurs less than two years and six months before the end of the term, the Governor appoints someone to fill the unexpired term and there is no election.'" Otherwise, West Virginia Gov. Joe Manchin (D) "would appoint an interim replacement, and a special election would be held in November to determine who held the seat in 2011 and 2012." With the death of Byrd and a declaration of a vacancy within days, "there could potentially be an election later this year, although there might be some ambiguities arising from precisely when and how the vacancy were declared," Silver writes.
by Santosh Rao, staff writer



Editors and Staff:

Editor: Anthony Wilson
Senior Editor: Kimberley Lufkin
Editor in Chief: Amanda Wolfe
Contributing Editors: Kate Ackerman, Daniel Esquibel, Justyn Ware
Senior Copy Editor: Michael Pogachar
Staff Writers: Brittany Hackett, Ryan Holeywell, Julia Moss, Santosh Rao, Zach Swiss, Matthew Wayt
Top News
Piling On the Cuts
A proposed rule from CMS includes a provision that could impose an additional 6.1% reduction to Medicare's physician reimbursement rates beginning in 2011, on top of the 21.3% cut scheduled to take effect in December.
How 72 Hours Can Cost Billions
Hospitals are seeking guidance from CMS regarding a recently enacted provision governing the first 72 hours of a patient admission, saying the measure will strain facility resources and reduce Medicare payments by more than $4 billion across a decade.
No Penicillin for Bessie
FDA yesterday issued draft guidelines recommending that farmers administer antibiotics to food-producing animals only when necessary to preserve their health.
FDA Foreshadowing?
Two studies released yesterday -- two weeks before an FDA panel meets to determine whether diabetes treatment Avandia should be pulled from the market -- provide new evidence that the drug increases patients' risk for heart problems and stroke.