Vaccine maker MedImmune has voluntarily recalled 13 lots of vaccine against the pandemic H1N1 influenza because they have lost some potency since they were manufactured, the company said. The 13 lots recalled involved 4.7 million doses of the intranasal vaccine, which is based on a live, weakened virus, but officials believe most of them were administered in October and November when the product would have still been at full potency. The company still has 3,000 doses of the vaccine affected by the recall, but no one knows how many are in warehouses around the country. This is the second recall of a swine flu vaccine. Just a week ago, Sanofi-Aventis recalled 800,000 doses of vaccine for children because it too had lost some potency.
An Alabama commission headed by the governor took action this week that could clear the way for the state to sell the almost 150-year-old Bryce Hospital in Tuscaloosa to the University of Alabama. The Amendment 666 Bond Commission voted to authorize the state Finance Department to sell up to $139 million in state bonds for economic development. Commission members did not say what projects might be funded with the money, but part of the funds could be used to help fund the building of a new mental hospital if the Bryce property is sold.
The Joint Commission has released a series of interim requirements to the staffing effectiveness standards, which are set to go into effect July 1, 2010.
The standards, approved by the Standards and Survey Procedures Committee, were first proposed in draft form in April 2009 and went through two field reviews, first in June 2009 and again in September.
These standards are intended to stay in effect as The Joint Commission examines and reassesses issues with the current staffing effectiveness standards. The Joint Commission announced earlier this year that it would examine and overhaul its staffing effectiveness standards after determining that, as they stand, the existing standards did not benefit hospitals sufficiently for the amount of time and effort put into complying with the standards. Staffing effectiveness standards had previously rated among the most commonly cited standards during Joint Commission surveys.
Until the review is completed, The Joint Commission has implemented the following requirements:
The hospital or organization must provide governance with written reports on the following at least once a year (LD.04.04.05 EP 13): all system/process failures; number/type of sentinel events; if the patients/residents and the families were informed of the event; all actions taken to improve safety, not only proactively but also when actual events occur; and the results of all analyses related to the adequacy of staffing. (Further details are available under PI.02.01.01, EP 14.)
The organization must include analyses of staffing when the organization identifies undesirable patterns, trends, or variations in its performance related to the safety or quality (PI.02.01.01, EP 12).
Leaders in charge of organization-wide patient and resident patient safety programs must be informed when problems are revealed involving the adequacy of staffing. Leaders must also be informed of actions taken to resolve the issues identified (PI.02.01.01, EP 13; see also LD.03.05.01, EP 7 and LD.04.04.05, EP 13).
Those responsible for the hospital-wide/organization-wide patient/resident safety program must, once a year or more, review a written report of the results of any analysis related to the adequacy of staffing and any actions taken to resolve identified problems (PI.02.01.01, EP 14).
The interim standards will first appear in the July 2010 update to the Comprehensive Accreditation Manual and E-dition. Additional information on these interim standards can be found on The Joint Commission's Web site.
Service Employees International Union-United Healthcare Workers-West is boasting that its rank-and-file hospital workers in California, who secured new contracts in 2009, received pay hikes that were nearly double the national average—despite a tanking state economy that is among the worst in the nation.
SEIU-UHW-represented hospital workers, on average, received a 4.3% wage increase for the first year of their contract in 2009. That does not include the back pay and signing bonuses many members also received on top of the wage hikes. In comparison, an analysis of collective bargaining data by the Bureau of National Affairs shows that nationally the average first-year wage increase bargained was 2.3% for 2009, SEIU-UHW said in a media release.
"SEIU-UHW hospital members have won amazing settlements in 2009 thanks to the unity of 150,000 members and their commitment to improving work and patient care standards," said SEIU-UHW Trustee Dave Regan. "That members have achieved these contracts in this economy makes it even more impressive."
More than 7,300 SEIU-UHW members at 20 healthcare facilities are covered by contracts settled in 2009. This includes a first-year wage increase of 7.8% at Sutter Roseville Medical Center; 3% at John Muir Medical Centers in Brentwood, Concord, and Walnut Creek; 6% increase at Tri-City Medical Center in Oceanside; and 4% at Stanford Hospital in Palo Alto.
"Given the difficult economy, we knew contract negotiations would be challenging this year. Being a part of a strong union, we had the support we needed to sit down at the bargaining table and get a strong contract. It not only included an increase in wages, but protected our healthcare," said Bruce Allen, a radiologic technologist at Sutter Roseville Medical Center and a member of the SEIU-UHW bargaining team.
Hospital workers in Daughters of Charity system facilities in both Northern California— O'Connor Hospital in San Jose, Saint Louise Regional Hospital in Gilroy, Seton Medical Center in Daly City, and Seton Coastside in Moss Beach— and Southern California—St. Francis Medical Center in Lynwood—received at least a 3% increase, as well as 18 months of back pay.
Other California contracts settled by SEIU-UHW members in 2009 include: Alameda Hospital, Chinese Hospital in San Francisco, Hazel Hawkins Memorial Hospital in Hollister, Moreno Valley Community Hospital, Sutter Amador Medical Center in Jackson, Sutter Delta Medical Center in Antioch, Sutter Solano Medical Center in Vallejo, and Washington Hospital in Fremont.
SEIU United Healthcare Workers-West is the largest hospital and healthcare union in the western United States with more than 150,000 members, and is part of the 2.1 million-member SEIU.
(Update: Dec. 29. Robert Dicks, senior manager of media relations at Lucile Packard Children's Hospital at Stanford, says the SEIU-UHW has exaggerated the pay increases in the contract reached with his hospital. "A new, two-year SEIU-UHW contract was ratified in a vote on Aug. 27, 2009, for both Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. That new contract provided the following: 2% across-the-board wage increases each year; An additional 2% annual step increase for those eligible.")
St. John Health System in Tulsa, OK, will pay the federal government more than $13.2 million to settle self-disclosed allegations that it reportedly billed Medicare and Medicaid for services that were tainted by the health system's incentive payments for referring physicians.
In April 2008, St. John conducted a voluntary internal audit and then submitted a self-disclosure report to HHS' Office of Inspector General raising concerns that agreements with 23 physicians and physicians' groups may have run afoul of the Stark Law prohibiting kickbacks, the False Claims Act, and other federal statutes.
"St. John Health System is committed to honesty and transparency in all of its dealings, which is why we conduct these internal audits. Consistent with our values, we believe that self disclosing these technical oversights was the right thing to do," Bob Sullivan, chairman of the St. John Health System, said in a media release. "The rules and regulations under Stark Law are extremely complex and continually evolving. Upon completing our internal audit, we implemented a new system-wide corporate compliance program to prevent any further reoccurrences."
The False Claims Act prohibits healthcare providers from billing a federal healthcare program for referrals from doctors with whom the providers have a financial relationship. Additionally, the Anti-Kickback Statute prohibits the payment of kickbacks for the referral of services that are paid for under a federal healthcare program.
"This case reflects how we work with providers who self-disclose serious misconduct to efficiently and fairly reach a resolution that protects federal healthcare programs and their beneficiaries," said Daniel R. Levinson, inspector general for HHS.
Health and Human Services Inspector General Daniel Levinson has agreed to a request from Sen. Bill Nelson (D-FL) to look into charges that 96% of wholesale prices of brand-name prescription drugs were sharply increased in anticipation of healthcare reform. The investigation will look at how high prices are impacting Medicare and Medicaid.
The charge stems from an AARP study, cited in a New York Times article last month, that said wholesale prices of the drugs rose around 9.3% this past fiscal year, which ended Sept. 30. This reported increase occurred as overall inflation was holding at 0.3%, according to critics of the price increase.
The increase has also caught the eyes of House legislators on the other side of Capitol Hill. Representatives Henry Waxman (D-CA), chair of the Energy and Commerce Committee, and Charles Rangel (D-NY), chair of the Ways and Means Committee, similarly have asked the Government Accountability Office to look into the charges as well.
At an Energy and Commerce Health Subcommittee hearing earlier this month on the topic, the increase in brand-name drug prices were contrasted with 8.7% decline in the price of common generic drugs during the same time. Overall, generic drugs have had an average decline in price every year since 2004, with decreases averaging between -0.6% and -11.5%, testified Stephen Schondelmeyer, PhD, professor of pharmaceutical management and economics at the University of Minnesota College of Pharmacy.
The recent increases "in prescription drug prices shocked everyone," said Waxman at the hearing. Of concern was the agreement that pharmaceutical manufacturers had pledged to cut $80 billion in costs during the next 10 years as part of an agreement to back health reform.
At the hearing, Rick Smith, senior vice president for policy and research with the Pharmaceutical Research and Manufacturers of America (PRMA), said that recent government reports had actually shown prescription drug cost slowing down "dramatically since the beginning of the decade—from a high double-digit growth rate to one in the low to mid single digits."
He added that as this slowdown in cost growth has occurred, other reports have claimed that brand drug prices are rapidly increasing, but "these reports do not reflect the way that the prescription drug market functions and therefore exaggerate prescription drug price trends."
Nelson has been critical of the $80 billion agreement. In fact, he called for a larger share of savings from the pharmaceutical manufacturers during a Senate Finance Committee hearing in September.
In an amendment, he proposed that the pharmaceutical industry "surrender a financial windfall" it gets on drugs sold to Medicare patients who also qualify for Medicaid, called "dual eligibles." The amendment, which Nelson said would saved taxpayers an estimated $106 billion over 10 years, was based on estimates provided by the Congressional Budget Office. It was defeated in a 13-10 vote at that time.
During the recent skilled nursing facility (SNF) Open Door Forum, the Centers for Medicare & Medicaid Services (CMS) eased some providers' concerns about preparing for the Minimum Data Set (MDS) 3.0 by announcing a variety of training opportunities that will take place over the next year.
CMS released chapters 1, 3, and 5, and appendices A through H of the new Resident Assessment Instrument (RAI) User's Manual for the MDS 3.0 on November 24 and plans to release the remaining sections of the RAI User's Manual (chapters 2, 4, 5, and 6, and Appendix C) sometime this month. According to CMS officials, the agency is still on schedule for the October 1, 2010 implementation of the new resident assessment tool.
"Nothing has changed in regards to the training schedule; we are still on target and working hard on pulling together pieces of the training opportunities we are providing," said Christina Stillwell-Deaner, RN, MPH, PHP, a CMS representative.
The MDS 3.0 training opportunities announced during the call are as follows:
A satellite broadcast series of MDS 3.0 training, which will be available through the CMS digital network and as Webcasts on the surveyor training Web site. These training sessions are scheduled as follows: May/June 2010 – How to code the MDS 3.0; and June/July 2010 – Impact on LTC survey processes and payment system.
Two train-the-trainer conferences will take place in Baltimore, MD: March 15-19: This conference is specifically for state agency RAI coordinators, long-term care surveyors, and state Medicaid agency representatives; and April 13-15: This conference is specifically for nursing home providers and stakeholder and professional groups and associations.
A series of MDS 3.0 training teleconferences for vendors. The first will take place on January 14, 2010 at 2 p.m. eastern. A notice containing the details of this teleconference will be sent to the vendor community within the next week.
Web-based training in the summer of 2010.
A nursing home distance-based training opportunity, possibly in the form of a Webinar or ODF, to allow providers to hear about the MDS 3.0 directly from CMS. No date has been set for this training opportunity yet, but CMS is looking at the spring or summer of 2010.
The year 2009 was an eventful, some would even say historic, year in healthcare. Washington spent most of the year cobbling together healthcare reform legislation, but those in the healthcare industry didn't sit by and wait for lawmakers to develop solutions to the healthcare system.
Health leaders spent 2009 doing what they always do—trying to provide better care to their patients.
But what exactly were they doing? Here's a list of the five best and five worst developments in healthcare in 2009.
The Five Best Things
1. The very best thing about healthcare in 2009 is the new-found appreciation that there is wide geographic variation in quality and amount of care patients receive, and the cost of providing it, although the reasons remain unclear. An article in the New Yorker by surgeon Atul Gawande called "The Cost Conundrum" drew upon statistics published in the Dartmouth Atlas. Gawande went to parts of the country that varied the most to examine the differences, and he suggested that our healthcare system rewards quantity of care, not necessarily quality.
More health executives and physician leaders as well as patients are beginning to understand why it's not OK to provide more care, unless it means people will have better quality lives as a result.
2. There is a new emphasis on getting more Americans health coverage, and on holding health insurance plans accountable for the care they provide. The goal of the administration and many in Congress working for health reform is to make sure that no one is denied coverage based on a pre-existing condition. It remains unclear, however, whether insurance plans will in effect deny coverage by charging exorbitantly high premiums to those with existing disease or high risks of being diagnosed.
3. James Lott, executive vice president of the Hospital Association of Southern California, which represents 157 hospitals in six counties, named as number one on his list of the best: "The Obama Administration's reversal of the Bush-era restrictions placed on the use of embryonic stem cells to develop cures or treatments for diseases and medical conditions that cause human suffering, premature and often agonizing death, and whose treatment contributes mightily to the high cost of healthcare." This is a good thing, but it remains to be seen whether it will result in meaningful care in the near future. Fingers are crossed.
4. An increasing number of Web sites allow healthcare consumers to compare geographic- and facility-specific variations in pricing, from actual outcome measures, such as mortality, falls or rates of infection. There are also an increasing number of sites that publish process measures, such as whether procedural steps in evidence-based care were performed, for example, prescribing beta blockers to certain heart patients.
5. A growing recognition among providers, based in at least two recent research papers, that the impact of radiation exposure during imaging exams is not an abstract one. Rather, it carries a quantifiable risk of cancer and other undesirable health effects.
The National Cancer Institute estimates nearly 30,000 excess cancers occurred from the 72 million CT scans in the U.S. just in 2007. About half of those cancers may be lethal. Two-hundred and sixty patients at Cedars-Sinai Medical Center in Los Angeles gave patients undergoing brain perfusion CT scans seven or eight times their dose of radiation. Patients at three other hospitals undergoing CT scans to detect stroke similarly received overdoses of radiation.
The 5 Worst Things
1. H1N1 and the way it has been handled by various governmental agencies, from vaccine distribution and prioritization, to guidance on the use of N-95 respirators, to details about risk factors for patients.
Lott of the Southern California Hospital Association says: "The government's handling of the H1N1 swine flu tops my list of the worst things that happened in 2009. The management of information, the poor inter-governmental agency coordination, and the mismanagement of distribution of vaccine by federal, state, and local government agencies was like watching an episode of the Keystone Cops."
On the upside, numerous lessons can be gleaned from this experience to better prepare for future pandemics and disasters.
2. Disintegration of what could have been intelligent, informed conversation about controlling costs of end-of-life care—which is useless in prolonging quality of life—into a histrionic shouting matches about death panels, exacerbated by tea baggers and unreasonableness.
3. The inability of hospitals to check with a federal database to learn whether health providers they might hire have any poor disciplinary or behavioral track records. Some 100,000 health providers disciplined for abuse, fraud, and other kinds of harm may still be treating patients because a law requiring disclosure of their records to potential employers has gone unimplemented for 22 years, prohibiting hospitals from knowing about their practitioners' questionable backgrounds.
Hospitals, nursing homes, and other providers should have access to the federally run Healthcare Integrity and Protection Data Bank (HIPDB), but a bureaucratic blockage at the federal level has prevented access.
4. There remains a dearth of comparative effectiveness research so health consumers will know what they're getting for their money. And health providers will understand the true value of what they may be doing out of habit.
We said in the best things that patients are increasingly able to review quality measures for care providers. And that's still a good thing.
But Steven Spear, a senior fellow at the Institute for Healthcare Improvement and author of the book Chasing the Rabbit, believes that today, patients still don't really have informed choice, in large part because providers aren't truly motivated to publish meaningful results on outcomes.
They make decisions about their choice of providers based on, say, whether they have a coffee shop nearby, the color of the rooms or what a neighbor said. "The good news of this, however, is that we're starting to talk about it," Spear says.
Spear says that if he were a health provider, "I want to inform the public so they would choose me. If you run a provider organization, the best prescription is advertise your performance, compare it to your neighbor's and then, patients and payers will move in your direction."
5. Health literacy and lack of personal responsibility in one's health remain a problem in today's healthcare. That's the bad news. The flip side is that there is increasing discussion by health insurers and other payers about rewarding patients, perhaps with refunds of their copayments, or through lower premiums, to become more health literate and personally responsible, perhaps through better diet, better adherence to treatment programs or closer attention to their lifestyles. There's more emphasis than ever before that for a large percentage of patients, better disease management is well within their control.
The costs of healthcare reform being pushed through Congress by Democrats will be felt long before the benefits. Proposed taxes and fees on upper-income earners, insurers, even tanning parlors, take effect quickly. So would Medicare cuts. Benefits, such as subsidies for lower middle-income households, consumer protections for all, and eliminating the prescription coverage gap for seniors, come gradually. Most of the 30 million uninsured helped by the bill won't get coverage until 2013 at the earliest, well after the next presidential election. More than two-thirds of Americans get their coverage through large employer plans and their premiums won't go up because of the legislation, according to number crunchers at the nonpartisan Congressional Budget Office. But Congress can't abolish medical inflation, so don't expect premiums to drop. For people who buy their own insurance policies, about one of every six Americans, premiums will go up. But that's for better benefits prescribed under the legislation. And about half of them would get tax credits to substantially lower their costs.
As the Senate lumbers toward passage of its healthcare bill, Democrats are looking ahead to the potentially difficult process of reconciling its substantial differences with the more liberal House version—the last major obstacle before President Obama can sign landmark legislation into law. Democrats are hopeful that the momentum generated by the long-awaited Senate vote—and the high political stakes involved in finishing the job—will grease the wheels of negotiations with the House. But after lawmakers enjoy what is left of the holiday season in their home states, they will return to wide and deeply held differences between the House and Senate bills on federal funding for abortion and the liberals' dream of establishing a "public option"—a government plan that would compete with private insurers—to guarantee access to affordable insurance. Negotiators also will have to hammer out disagreements that will determine how quickly the bill takes effect, what taxes will be raised, and other items that reach deeply into every hospital, doctor's office, and home medicine cabinet.
