The Food and Drug Administration (FDA) has been lax in permitting numerous drugs designed to treat life-altering illnesses—such as HIV/AIDS or cancer—to remain on the market without their manufacturers providing required follow-up studies to show their effectiveness, according to a new Government Accountability Office (GAO) study.
Between 1992 and 2008, the Food and Drug Administration (FDA) approved 90 applications for drugs using an accelerated approval process to quickly get to market drugs aimed at treating serious or life-altering illnesses. However, weaknesses in FDA's monitoring and enforcement process have hampered its ability to effectively oversee post-marketing studies of many of those drugs, GAO said.
In efforts to expedite approval of these drugs, FDA began in 1992 to use a process based on "surrogate endpoints," which required that "drug sponsors complete post-marketing studies to confirm the drug's clinical benefit." These endpoints can include laboratory measures, such as blood pressure—instead of more direct clinical evidence, such as preventing strokes.
"Once those drugs are on the market, the FDA needs to monitor the outcomes," said Sen. Charles Grassley (R-IA), the ranking minority member of the Senate Finance Committee, who had requested the study. "The report should serve as an impetus for the FDA to improve the post market surveillance of these drugs, giving patients and their doctors' meaningful information and necessary safeguards."
FDA had required drug sponsors to conduct 144 post-marketing studies associated with the 90 applications. By the end of 2008, two-thirds of the applications were classified as closed—meaning that drug sponsors had met FDA's requirements for these studies. However, a third of the remaining studies have been classified by FDA as "open" for an extended period.
Although FDA has authority to expedite removal of a drug from the market if a sponsor does not complete a required study—or if a study fails to confirm a drug's clinical benefit, it has not specified the conditions that would prompt it to do so, GAO said.
One of the examples is the case of Shire Laboratories'ProAmatine, a medication used for low blood pressure. The required study been incomplete since 1996. In its study, GAO found that ProAmatine had generated more than $257 million in sales up through 2008, even though "the clinical benefit of the drug has never been established."
FDA officials this summer indicated that they planned to issue a final administrative action letter to the sponsor of ProAmatine and generic manufacturers in a final effort to obtain completion of the required study, GAO said.
The Centers for Disease Control and Prevention has chosen GE Healthcare's electronic medical records network to provide surveillance data for H1N1 and season influenza activity.
Under the agreement, GE Healthcare will submit a real-time update on the status of influenza activity every 24 hours by monitoring a national database of nearly 14 million patient records.
GE Healthcare says it will glean the information from its Medical Quality Improvement Consortium, a repository designed within HIPAA guidelines for providing anonymous clinical data.
Participating physicians automatically contribute anonymous data to MQIC each day through normal use of GE's Centricity EMR when they document information collected during patient visits to physician offices and clinics. GE Healthcare says the MQIC database is growing by nearly 30% each year and has been validated in peer-review studies as representative of demographic and co-morbidity averages in the U.S. population.
"The data passed along by doctors is a clinically-accurate representation of H1N1-related symptoms and trends," says Peter Basch, MD, an internist with MedStar Health, in Washington, DC, which is a program participant. "(That) enables CDC researchers to track hotspots as the flu season evolves and quickly communicate that information to healthcare providers to improve awareness and response for better clinical outcomes."
MQIC collates clinical data documented by primary care physicians using GE's EMR platform, which allows CDC to track clinical symptoms, such as fever, nausea and chills, prescriptions written, and vaccination rates, as well as variables including procedures performed, pregnancy and patient age, within 24 hours of being documented in thousands of participating doctors' offices across the country.
"This is a strong example of the power of digitizing the nation's medical records," says Jim Corrigan, GE Healthcare's IT vice president and general manager. "With EMR data, not only are we able to accelerate the reporting of any aggregate changes to the health of the U.S. population, we're able to provide valuable and timely clinical data to health professionals."
CDC says it selected GE Healthcare because of its database's built-in reporting capabilities. The resulting information helps the CDC understand the characteristics of H1N1 outbreaks and determine who is most at-risk for developing complications from the virus. Traditionally, this data is collected using insurance claims data, a process with a significant lag time.
Physicians who consider themselves religious are not more likely to care for the poor than doctors with no religious affiliation, according to a new study. "The most religious are no more likely to care for the underserved than are the least religious. That to me was both a surprise and a disappointment," said lead author Farr A. Curlin, MD, assistant professor of medicine at the University of Chicago.
This article from the Washington Post provides an account of one physician's trip to the ER for a simple case of shingles, and the $9,000 hospital bill that followed. Jack Coulehan, MD, had already diagnosed himself when he went in, and even had a treatment plan in mind, but by the time he got out of the ER he had consults with an ophthalmologist an neurologist, two MRIs, and a CT scan—all of which were unnecessary, Coulehan states.
For physician practice coders, the transition to ICD-10 in 2013 might not be as bad as anticipated. Why? The most obvious reason is that physician practice coders don't have to worry about procedure codes, as physician practices will continue to report CPT codes for procedures. These coders only need to check for annual CPT updates, which is what they currently do. However, one major change will be the superbills update that will include ICD-10 codes that represent the most commonly used diagnoses for the practice's patient populations.
Because of CMS, providers have access to free resources to help them prepare for the transition to ICD-10. CMS and the CDC have created a set of tables that crosswalk the two versions of disease classifications. The tables, called general equivalence mappings (GEM), are text files that include information coders need to get acquainted with how common diagnosis codes will translate to ICD-10. Access the GEM and additional information about how to use them on CMS' Web site.
Although many crosswalks exist, some ICD-10 codes do not have a predecessor in ICD-9. Although this is the exception rather than the rule, CMS reminds coders that this means the GEM tables won't serve as an all-encompassing resource. Coders must continue to rely on coding books and adhere to coding rules.
To receive guidance on commonly used codes in ICD-9 versus ICD-10 and more, access HCPro's ICD-10 Watch blog at http://blogs.hcpro.com/icd-10.
The American Health Information Management Association offers many free and valuable tools for physician practices on its Web site, www.ahima.org.
The American Academy of Professional Coders Web site, www.aapc.com, offers additional resources, including an example of a 'before and after' superbill created by the American Academy of Family Practitioners.
The transition to ICD-10 is finally going to happen. Fortunately, coders have three years to prepare for the conversion and resources are readily available. Coders should seize the opportunity to take a sneak peek at what the changes will look like for their practice.
This article was adapted from one that originally appeared in the November 2009 issue ofThe Doctor's Office, a HealthLeaders Media publication.
When several patients needing urgent or emergent surgery arrive at a hospital simultaneously, who decides which case gets into the OR first? For true emergencies, the decision is generally straightforward, with the patient rushed into the first available room.
But in many other situations, the decision is not as clear: Should the patient with an open fracture go first; should it be the patient with an ectopic pregnancy, or perhaps the patient with an intestinal obstruction? Does the most senior surgeon get the first available OR slot? Should the decision be made on the basis of first-come, first-served? Or maybe the most assertive surgeon gets his or her case in first?
Often the decision falls to the anesthesiologist of the day in the OR. But no matter who makes the decision, the competition between surgeons over this matter, and the daily arguments with anesthesiologists, cause frustrations to both surgeons and anesthesiologists. And at times, patients end up waiting for surgery longer than is clinically optimal.
Ideally, the decision should be based on an objective measure that reflects the clinical needs of the patient and gives surgeons, anesthesiologists, and OR staff a predictable and fair system for prioritizing their cases.
An Innovative Approach
Wellstar Kennestone Hospital, a 600-bed hospital in Marietta, GA, working with Press Ganey, developed an innovative approach to this problem. As part of a significant initiative to improve patient flow through the OR, the surgical services committee—a committee composed of well-respected surgeons and anesthesiologists representing different services—developed criteria for classifying all emergent and urgent cases based on the medical needs of the patient.
The classification system was then used to determine the order in which cases were taken into the OR. It created a system that was fair, predictable and based on clinically-defined criteria. The clinical urgency system was used in conjunction with other patient flow improvement initiatives, including designating separate ORs for these add-on cases.
The surgical services committee decided to use five categories to classify its urgent and emergent cases. Time limits were set for each category, defining the maximum amount of time that should pass between the time a case was posted and when the patient was taken into the OR. Each specialty reviewed its common procedures and placed them into the category into which they would most commonly fall.
The five categories, and their corresponding time limits, were:
A. Acute life and death emergencies (30 - 60 minutes). Examples: Massive bleeding and airway emergencies.
B. Emergent but not immediately life threatening (< 2 hours). Examples: Acute spinal cord compression, bladder rupture, ectopic pregnancy.
C. Urgent cases (< 4 hours). Examples: Asymptomatic foreign body, appendicitis with sepsis/rapid progression, biliary obstruction, open fracture.
D. Semi-urgent (< 8 hours). Examples: Appendicitis, closed reduction of fracture, empyema.
Once the categories were developed and accepted by the surgeons, they began to use them to specify the urgency of add-on cases as they posted them. The system works in the following way:
When a surgeon posts a case, he or she classifies its urgency by using one of the five categories based on the needs of the patient. The appropriateness of the classification is never questioned at the time the case is posted but may be reviewed by the committee retrospectively. The order in which add-on urgent/emergent cases are then scheduled into the OR is based on the urgency of the case and the amount of time that has passed since the case was posted. If two cases within the same category arrive close together, they are taken in order of first-come, first-served.
The surgeon booking the case is responsible for categorizing the case, based on his or her knowledge of the clinical needs of the patient. For example, a surgeon can call an appendicitis case a 'B' case if he thinks that the patient's condition warrants surgery within two hours, even though most appendicitis cases are usually considered to be in the D (within eight hours) category. At the time of booking, no one can question the surgeon on this decision since it is assumed that he or she is the one with the most accurate assessment of the situation.
Monitoring Compliance
Like any system, this one can be manipulated, and oversight is necessary to maintain consistency and monitor compliance with the urgency categories. At WellStar Kennestone Hospital, the surgical services committee took on this role. Each month, the committee reviewed all 'A' cases and any other cases where the appropriateness of the urgency classification was questioned by another surgeon, an anesthesiologist, or surgical staff.
If further review appeared necessary, a member of the committee would talk with the surgeon in question, and if systematic or frequent problems occurred, the surgeon would be asked to appear before the committee to discuss the cases. This peer review system is critical to maintain accurate categorization and to avoid any gaming of the system. The review can also lead to revisions to the category guidelines over time.
Results
With the implementation of this approach to scheduling urgent/emergent cases into designated ORs, waiting times for these cases declined by 18% overall at WellStar Kennestone Hospital. For urgent and semi-urgent cases—types of cases that typically get delayed—the decreases in waiting time were even more dramatic, with waiting times decreasing 77% for C cases (maximum wait of four hours) and 33% for D cases (maximum wait of eight hours). In addition, E (non-urgent same day) cases no longer got pushed into nighttime hours—from 11 p.m. until 7 a.m.—because there was more time during the day to get these cases completed. The number of staff needed at night was reduced since it had only to care for more urgent cases.
The surgeons were pleased that their patients were getting into the OR more quickly. Surgeons, anesthesiologists and OR staff appreciated the transparency of the system. "Since we are able to get critical cases done more quickly we end up with less of a backlog during the day, and no longer find ourselves doing hip fractures at midnight," said an anesthesiologist at WellStar Kennestone.
Osnat Levtzion-Korach M.D, MHA is a senior medical consultant with Press Ganey Associates; Kenneth G. Murphy, MD, is president of Georgia Anesthesiologists, PC; Susan Madden, MS, is vice president for analytics with Press Ganey; and Christina Dempsey, RN, CNOR, MBA, is senior vice president for clinical operations with Press Ganey.For information on how you can contribute to HealthLeaders Media online, please read our Editorial Guidelines.
Think back to Atul Gawande's influential article about healthcare costs in the New Yorker earlier this year and the debate it sparked about overutilization. The article was forwarded throughout the industry, became mandatory reading at the White House, and may even shape future healthcare policy. All of this from a relatively simple comparison of Medicare costs in two Texas towns.
Kind of broad brush, isn't it? There are a lot of good physicians who don't overutilize—even in McAllen, TX, where Medicare spends $15,000 per enrollee, almost twice the national average. And there are plenty of physicians who overutilize in regions that look below average on paper, at least according to the Dartmouth Atlas and other studies that measure healthcare spending geographically.
The problem is that policymakers are trying to address how physicians use resources, yet most of the data that drives policy decisions and healthcare research measures how regions use resources.
CMS is trying to develop more granular data at the physician level. The Government Accountability Office, MedPAC, and the Congressional Budget Office have all recommended in recent years that CMS profile physician resource use and provide feedback as a step toward improving Medicare efficiency.
But how?
MedPAC has explored episode-based profiling, which measures the resources used for treating a particular episode of care or a specific illness. But we're still locked into a fee-for-service system, so other options have to be considered.
This week, the GAO released a report evaluating per capita profiling, a method that measures a patient's resource use over a fixed period of time and connects that resource use to physicians.
The report focused on cardiologists, radiologists, internists, and orthopedic surgeons in Miami, Phoenix, Pittsburgh, and Sacramento, and risk adjusted data to account for patients' health conditions.
In each of the four metropolitan areas, physicians were fairly stable in their resource use, even when their patients' resource use varied. And patients seen by "high-resource use" physicians generally were heavier users of institutional services (such as hospital services) than those seen by lower resource use physicians.
Those findings aren't all that remarkable on their own. The purpose of the report was really to determine whether per capita profiling could be used to measure physician resource use, and the results suggest it can. And the entire point of figuring that out was to go one step further and provide physicians' feedback on their resource use.
Will that have any effect? Researchers asked private insurers who have tried similar programs that question and concluded that feedback has no more than a moderate influence on physician behavior. Moderate could mean many things, and the GAO seems to be hoping that feedback from CMS will be more of a motivator than feedback from a private payer "because of the relatively large share of physicians' practice revenues that Medicare typically represents."
Most physicians like data and enjoy receiving feedback on their own performance. Their competitive nature kicks on and they will often improve in areas they didn't even realize they were lagging behind, even resource use.
Even if the impact is only "moderate," that could add up to a lot of dollars.
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While efforts to fight healthcare fraud are addressed in both Senate reform bills, more is needed still at the federal level to tackle fraud and abuse at both the public and private sector levels, said Sen. Patrick Leahy (D-VT), chairman of the Senate Judiciary Committee, at a hearing on Wednesday on "Effective Strategies For Preventing Health Care Fraud."
"The scale of healthcare fraud in America today is staggering," Leahy said in testimony opening the hearing. According to conservative estimates, "about 3% percent of the funds spent on healthcare are lost to fraud more than $60 billion dollars a year," he said. In the Medicare program, the Government Accountability Office estimates that more than $10 billon dollars was lost to fraud just last year, he added.
"Whether it is federal dollars or private dollars, fraud is draining billions and billions away from providing effective healthcare. We must work together to ensure that we have tough and effective measures in place to prevent healthcare fraud and provide accountability," said Leahy, who after the hearing introduced a new bill calling for strengthening the "government’s capacity to investigate and prosecute waste."
The committee was informed of new efforts by the Department of Health and Human Services to eliminate fraud by HHS Deputy Secretary Bill Corr. For instance, the Centers for Medicare and Medicaid Services (CMS) is in the final stages of building an integrated data repository (IDR) that "will for the first time in Medicare’s history bring all Medicare claims data together in one centralized data repository," Corr said.
Using the IDR, CMS is expected to go beyond the "current practices of application and claims review" by using new technology to identify irregularities in claims data—such as "unusual, clinically inconsistent, or high volume billings."
One important tool to help fight durable medical equipment (DME) fraud is competitive bidding for suppliers, Corr said. In one effort that became effective in early October 2009, most DME suppliers participating in the Medicare program are now required to have both a surety bond and accreditation from a deemed accrediting organization.
"Most non physician suppliers of durable medical equipment are required to obtain a $50,000 or higher surety bond—thus deterring illegitimate suppliers from enrolling in Medicare," Corr said. This combination of the surety bond and accreditation requirements helps ensure that CMS is only doing business with legitimate partners and expel fraudulent suppliers from the program.
Assistant Attorney General Tony West spoke about the results of the Health Care Fraud Prevention and Enforcement Prevention Action Team—better known as "HEAT"—which is the combined HHS and Department of Justice effort announced this past May to combat healthcare fraud and abuse. Strike forces are now operating in South Florida, Los Angeles, Detroit, and Houston.
The HEAT initiative, for instance, was involved in the case last month in which Pfizer and its subsidiary agreed to pay $2.3 billion to resolve civil and criminal liability claims resulting from the promotion of certain pharmaceutical products.
But while the initiative is new, the collaborative effort has been ongoing between the two departments since 1997. During that time, more than $15 billion has been returned to the federal government, West said.
During questioning from the senators, West acknowledged that it was "important to look at the problem of fraud in healthcare as a holistic problem—not just as a public problem or not just as a public sector problem."
In the bill being introduced by Leahy and Sen. Ted Kaufman (D-DE), they were looking to increase federal antifraud spending by $20 million per year through 2016. They also call for improvements to the federal sentencing guidelines and to forfeiture, money laundering, and obstruction statutes.
Violence at Boston hospitals over the past eight days—including a fatal patient shooting—proves that healthcare security is an unpredictable business.
While it's hard to immediately learn lessons from this latest series of incidents, safety and security professionals at several medical centers offered steps they take to prevent and respond to workplace violence.
The following three incidents occurred recently at Boston medical facilities:
On Tuesday, an off-duty security guard shot and killed a patient who had allegedly stabbed a psychiatrist just moments earlier in a medical office building owned by Massachusetts General Hospital, according to the Boston Police Department. The security guard, who was legally carrying a weapon, didn't work for the facility and happened to be in the medical office building at the time. The psychiatrist was expected to recover from her injuries, the Boston Globe reported.
On Sunday, a man was stabbed in the waiting room at Boston Medical Center after a fight broke out between two groups of people, The Globe reported. The victim was expected to live, and police had not arrested any suspects as of Wednesday.
Last Thursday, a man was arrested for allegedly attempting to rape an employee at Mass. General, according to Boston police. The suspect, a convicted sex offender on release, allegedly grabbed the victim from behind in a women's restroom, slammed her head into the ground, and ripped her clothes before the victim was able to escape, The Globe said.
Tuesday's attack on the psychiatrist and subsequent shooting of the suspect at Mass. General garnered national media attention. However, Thomas Lynch, director of security for Baystate Health in Springfield, MA, warns that the circumstances surrounding that case make it hard to apply to other hospitals.
"I don't know how you plan for that [type of patient attack]," Lynch said. "And the response was out of left field, too, to have someone there [with a gun] … It's kind of amazing."
That said, as details emerge from the shooting it behooves other hospital officials to ask if they face similar risks at their behavioral facilities, says Steve MacArthur, safety consultant for The Greeley Company, a division of HCPro in Marblehead, MA.
Internal team can set protective measures Cape Fear Valley Health System in Fayetteville, NC, established a security threat assessment team 10 years ago, says Steve Schultz, safety officer for Cape Fear. The team is made up of representatives from the human resources, safety, security, employee assistance, and risk management departments.
Any employee who feels threatened by someone else—be it a domestic partner, patient, or coworker—can request a meeting with the team. Supervisors who become aware of threats against their personnel can also request a meeting.
"The [team] can meet on 20 minutes' notice," Schulz says. "Our goal is to have an action plan developed within 60 minutes of the notification." The team offers recommendations on how to keep the threatened employee safe both in the hospital and outside of work.
"We've had issues with threatening patients and family members," he said. "For the past four years or so, it's been domestic situations" getting the most notice from the team.
Domestic incidents also concern Dick Lange, HEM, facilities manager at St. Joseph's Hospital in Marshfield, WI, part of Ministry Health Care.
"As the economy continues to tank, domestic [violence], as well as folks facing healthcare costs that they have no way of paying, all increase the chance of an explosive episode," Lange says. Downsized security forces at hospitals exacerbate the problem. St. Joseph's active shooter policy calls for an immediate lockdown of the building in the event someone brandishes a weapon. Hospital employees, including security officers, are not called upon to confront someone with a firearm, and in many cases, workers throughout the facility are encouraged to lock patients and themselves in rooms until the dangers has subsided. St. Joseph's security officers carry batons and pepper spray, but not guns.
Policies should spell out precautions for weapons
Employees directly involved in a violent situation involving a weapon face a dangerous set of circumstances. Summa Health System in Akron, OH, is about to roll out its new active shooter policy, says Howard Hunt, system safety officer.
"It hasn't been implemented yet as our security staff has just started training from an outside company, and the safety committee is developing a training program for all other employees, with special training for high risk areas, such as the emergency department," Hunt says.
Summa's new policy will emphasize that employees in the midst of a violent situation take the following actions:
Don't risk harm to yourself or others
Maintain eye contract with the assailant, and pay attention to what is being said by the assailant
Do not speak unless spoken to—follow instructions from the person who has the weapon.
Attempt to keep the assailant in the immediate area
Never try to grab the weapon
Await further assistance from security or responding law enforcement
It's important to talk to authorities ahead of time about the potential for violence in the hospital. "Get your local law enforcement in and pow-wow," Lange says. "Find out what is reality and what is a pipe dream" in terms of security steps, which in many cases won't deter violence from occurring, but instead will become response goals, he said.
An interim final rule from the Genetic Information Nondiscrimination Act of 2008 (GINA) could cripple wellness, disease management, and population health management programs, according to DMAA: The Care Continuum Alliance, employer and wellness groups, and health insurers.
The departments of Health and Human Services, Labor, and Treasury offered a joint final regulation of GINA earlier this month that would have unintended consequences, says Tracey Moorhead, president and CEO of DMAA, formerly called the Disease Management Association of America.
President George W. Bush signed GINA into law on May 21, 2008 after the legislation passed Congress with only one opposing vote. The goal behind GINA is to stop discrimination in insurance and employment based on genetic information. Moorhead says the legislation defined "‘underwriting purposes' in a traditional manner," such as computing premium and contribution amounts under a health plan.
However, the joint final regulation goes well beyond that underwriting definition and includes discounts, rebates, payments, and premium differential mechanisms that are paid to people for completing health risk assessments (HRA) or participating in wellness programs, she says.
In announcing the new regulations this month, the three departments trumpeted that GINA will "help ensure that genetic information is not used adversely in determining healthcare coverage and will encourage more individuals to participate in genetic testing, which can help better identify and prevent certain illnesses."
They added that the interim final rule would not allow group health plans to increase premiums based on a member's genetic information, or deny enrollment, impose pre-existing condition exclusions or conduct "other forms of underwriting based on genetic information," according to the Department of Health and Human Services.
However, Moorhead says the final interim rule goes beyond the intent of the legislation that protected the use of employer wellness programs. It also prohibits collecting family health history prior to enrollment in a group plan and treats family medical history as genetic information.
"We do not believe that Congress intended to have this adverse impact on employer wellness programs. In fact, we believe this is in direct conflict not only with the current administration's goals in terms of prevention and wellness and health promotion that we have heard President Obama repeatedly talk about as a goal for his healthcare reform initiative, but also in direct conflict with the congressional goals for healthcare reform," says Moorhead.
These provisions would not allow health plans, employers, and disease management, wellness, and population health management organizations to use family history data to find at-risk members and could not use incentives to spark them to take part in wellness and disease management programs. The result would be fewer at-risk people involved in prevention programs (more than 70% of employers currently provide incentives to drive employee participation), higher chronic disease rates, and ultimately higher healthcare spending, says Moorhead.
Collecting family history is protected under current HIPAA statutes and the information is used to figure out which members would benefit most from enrolling in a wellness or disease management program. Instead of having that information available, health plans and population health management companies would have to ask members to self-identify, which Moorhead says is not the best way to help members manage their risk factors and chronic conditions.
"Certainly, it is not our intent to utilize health risk assessment-derived information for any purpose other than to promote the health and wellness of these populations. This information is currently protected by HIPAA and we fully support the intent of the GINA legislation and implementing regulation. However, we are very concerned about what we believe are the unintended consequences of this regulatory interpretation," says Moorhead.
If the interim rule remains, John Griffin, chief operating officer at HealthFitness, a Minneapolis-based wellness company, expects companies will remove the family history questions from HRAs. Griffin says HealthFitness' HRA, which is about 80 questions, includes two family medical history questions.
"Almost all HRAs will be intact, but we and everyone I have talked to will remove any family medical history in those HRAs," says Griffin.
Though only two questions, the results allow HealthFitness to reach out to people with family history health problems, such as cancer or heart disease, and target interventions. For instance, HealthFitness may ask women with a family history of breast cancer to get tested earlier than women without breast cancer in their family. Griffin says the interim final rule would have the biggest effect on disease management companies and programs because they deal with chronic disease.
DMAA recently sent a letter to the Senate leaders asking for clarification of the underwriting definition and asked for an immediate moratorium on the GINA regulation implementation.
The interim final rule is scheduled to take effect December 7, but the agencies will accept comments on it until January 5, 2010.
