you can get his background, you can also go to the university of colorado web site to get some background information on him. professor hatfield, thank you for being on "the communicators", and i hope you can come back. >> guest: thank you. i'd be happy to do so. >> host: and, as always, paul kirby, one of our regular guest reporters here on "the communicators." he's with "telecommunications reports." thank you. >> host: thank you. >> ahead on c-span2, a house panel looks at a proposed regulation that would ricket drive times for commercial truck drivers. then a look at the use of antipsychotic drugs on the use of dementia patients. after that, a live discussion on the economic trends and challenges facing young adults, and later the senate returns at

2 p.m. eastern for a period of general speeches followed later by debate and a roll call vote on judicial nominations. >> also today on the c-span networks a look at the progress and global efforts to eliminate malaria. a house panel will hear from medical health professionals about the future of drug and vaccine development. they'll also discuss the challenges in insuring the availability, affordability and safe distribution of anti-malaria medicine. live coverage from capitol hill begins at 3 p.m. eastern over on c-span3. >> television can be a teacher, and if we're going to have a debate, you know, on television in a courtroom and you drew the affirmative side of the debate, you could make probably more positive points. >> tuesday, a senate judiciary subcommittee meets to discuss televising the supreme court, and we'll be covering that hearing. you can learn more online at

c-span.org with our special web page devoted to cameras in the court. see public opinion polls and what the justices have said. you'll also find a link to c-span's youtube playlist with videos of justices and members of congress talking about cameras in the court. >> lawmaker recently held a hearing to examine the transportation department's proposed regulation that would restrict drive times for commercial truck drivers. a house oversight panel heard from trucking business representatives, commercial retailers and federal administrators on the potential economic impact of the rule on drivers and consumers. this house subcommittee hearing runs an hour and 45 minutes. [inaudible conversations] >> we welcome everyone to our hearing this morning. the price of uncertainty, how much the d.o.t.'s proposed

service rule can cost consumers. we want to get started, i'm glad we have our, my friend and ranking member here, mr. kucinich. we'll start with our owning statements, and i've got a longer opening statement than normal, so i'll read fast. [laughter] this last week ordinary people across this great united states have engaged in the annual tradition of shopping for christmas gifts to take advantage of black friday sales and cyber monday sales. the shopping season is vital to the survival of so many small retailers. 80% of all communities depend solely on trucks to deliver and supply the products sold in stores or delivered online. trucks moves $8.3 trillion worth of goods annually. unfortunately, these merchants and professional triers who bring the goods to market have a very good reason to be worried this year. the department of transportation

has produced a multibillion dollar regulation, the hours of service rule, that threatens to raise prices and cut revenues this holiday season, further jeopardizing our fragile economic recovery. d.o.t.'s hours of service rule which is only one of seven regulations president obama admitted impose an annual cost of at least $1 billion on the economy is being reviewed at the white house as we speak. this regulation will hurt an array of job creators from truckers to grocers to bakers and retailers, all of whom rely on trucking to operate. the rule, which has received nearly 30,000 comments, has been the subject of widespread and bipartisan concern. critics of the rule include multiple democratic senators and the small business administration's office of advocacy. at this time i'd like to enter into the record a comment letter from the office of advocacy. without objection, so ordered. in february, 2011, i joined with a bipartisan group who wrote the

u.s. department of transportation secretary mr. lahood to express the concern that altering the current hours of service rules is unnecessary and would result in more trucks and drivers on the road to transport the same amount of goods, increasing final product costs and con discretion on the nation's already-overcrowded highways. this letter points out that the proposed rules could actually decrease safety because they could cause drivers to rush, adding stress and increasing the likelihood of an accident. while i support the goals of increased highway safety and reducing the driver fatigue, this rule appears to be a solution in search of a problem. even d.o.t. admits that, quote, the data shows no decline in highway safety since the implementation since the 2003 hours of service rule, and its readoption in 2005 and the 2007 interim final rule. moreover, trucking-related accidents are at an all time low. the department of transportation's own data shows that 2009 saw the largest annual decline in fatal trucking

accidents on record. meanwhile, the number of truck miles traveled and the number of registered trucks has increased from 221 billion miles in 2004 to 288 billion miles today. the number of registered large trucks has also increased by nearly three million. accordingly, it appears the current rules are striking the appropriate balance. in order to justify the expensive regulation, it appears the d.o.t. is playing games with the numbers and using fuzzy math in an attempt to justify their action. one of our witnesses today will explain how d.o.t. is rigging the system. at this time i would like to also enter into the record a report entitled analysis for the 2011-2011 hours of service rule. again, without objection, so ordered. this report highlights the intent, excuse me, inventive methodologies and improbable assumptions d.o.t. uses to increase the net benefits of the rule. this study finds that the rule will impose a net cost to

society. i also want to emphasize there is a strong bipartisan agreement on the need to insure and improve highway safety. however, it is my sincere belief that the regulation could actually have a negative impact on safety. the purpose of today's hearing is to bring transparency to the rulemaking process so that we understand the full consequences of federal regulation before it becomes law. and with that, i now yield to the distinguished member from ohio, mr. kucinich. >> mr. chairman, thank you very much for holding this hearing and for the opportunity to make this presentation. this question's being framed around how much the proposed rule which limits the number of hours commercial truck drivers could be on the road could cost consumers, but i would respectfully submit there are far more appropriate questions, whether this proposed rule will insure our loved ones will be safe. it's the proposed rule, it's what it's all about, is saving

lives. truck driver fatigue is a serious safety problem that threatens everyone who gets on a highway every day. each year on average 4,000 people are needlessly killed and 100,000 are injured in truck crashes. evidence suggests that truck driver fatigue is a major factor in these crashes. under the hours of service rule currently in effect, truck drivers can drive more than 77 hours a week. think about that. you know, we're all used to thinking about a 40-hour week. when congress is in session, we probably put in an 80-hour week at least, i'd say, and you get tired. but if you're driving a truck with all of that machinery and mass in motion, there are consequences when fatigue sets in. there's a human dimension here that cannot be ignored. and under the amounts of driving currently allowed, 65% of drivers reported that they often or sometimes felt drowsy with driving. 48% have fallen asleep while

driving the previous year. and i will say this again. some of us in the legislature have had to drive a great denies. you're on a sedge, -- schedule, and you can get drowsy. it's happened to all of us. it happens. and we have to realize that truck drivers are not immune to this. you get the combination of tired truckers driving loads of 80,000 pounds can make a lethal weapon. there are brave people in the audience today who came to support stricter standards or because they've been unfortunate to have felt firsthand the devastating effects of truck driver fatigue. now, ed flattery is here with his son, peter, and they've submitted a statement for the record, mr. chairman, which i would like -- but i want to read from parts of his statement so the members of this subcommittee and others will know the real cost of truck crashes involving truck drivers. without objection, i'd like to submit his entire statement for

the record, but it's a compelling testimony. mr. slat erie, thank you and your son for being here. it was a beautiful, clear day on august 16, 2001, when my family's lives were changed photographer. forever. my wife susan and our two sons, peter and matthew, were returning home from a big family reunion in ohio which happens to be in my district. that was the home of susan's participants, george and ginger palmer. susan grew up in cleveland, and all of her family still lives in ohio. mr. slattery writes i would have been with them, but i was recovering from shoulder surgery. as they neared the 190 mile marker around 11:45 a.m., a truck driver behind the wheel of a triple trailer truck had fallen asleep and crashed into the back of our car. mr. slattery writes, in an instant i lost my wife, and peter and matthew had emergency surgery. following the impact with our

car, the truck went on to hit two other semis and four more passenger vehicles before stopping in the divider and bursting into flames. the weeks following the crash were juggling surgeries and meeting with funeral directors, always insuring someone was by peter and matthew's side. after about a month, the boys were stable enough to return to baltimore where we began dealing with the long-term effects of the crash including the loss of my wife, susan. peter was conscious and being move today a helicopter when he overheard the paramedics pronounce his mother dead. the long-term psychological effects are yet to be determined. matthew was in a coma for massive head trauma but is permanently disabled and requires round-the-clock care. our lives will never be the same, but i can work to reduce truck driver fatigue so another family will not have to suffer

the tremendous loss my family lives with every single day. the proposed rule would reduce costs to society. i urge the subcommittee no t to impede the progress the department of transportation has made to the rule and protect the safety and well being of our families. mr. slattery and peter whoever here, i just want you to know that we are going to be very sensitive to the concerns that are expressed here, and we thank you very much for attending this hearing so that you can listen to the testimony. thank you very much. thank you, mr. chairman. >> let me thank the ranking member for his statement. let me also express on behalf of the chair and the entire committee our sympathies to the slattery family and to your son peter and the loss you have suffered. obviously, we're all concerned about safety, and we just want to make sure that whatever rule is put forward does, in fact, protect people as best we can, but also takes into account the economic concerns that i think

are valid as well. so i appreciate that from our ranking member. does the gentle lady from new york wish to make an opening statement? >> no, thank you. i yield back. >> okay. we'll get right to -- does the gentleman, the doctor from tennessee have any -- okay. we'll get right to our witnesses, and let me introduce, first, we have mr. ed nagel, president and ceo of nagel companies in ohio and has been involved in the trucking industry for over 30 years. we also have mr. glen keysaw, executive director of transportation logistics for the associates food stores company. mr. rob mackie is president and ceo of the american bakers' association, has served on the food industry coalition or hours of service regulation, so worked directly with the issue in front of us. we have mr. frank miller, director of logistics at babcock and moore in mulberry, florida, and has worked on transportation

irk shoes for over 20 years. we have with us, also, mr. henry jasmine. he was vice president and general counsel for advocates for highway safety and dr. jesse david, economist with 15 years of experience in regulatory policy. all witnesses are sworn in, so if you'll just, please, stand and raise your right hands. do you solemnly swear or affirm that the testimony you're about to give will be the truth, the whole truth, nothing but the truth, and if you do, just nod in the affirmative. let the record show that everyone answer inside the affirm ty, and we're going to start with mr. nagel. you guys know the rules, you get five minutes, and stay as close to that as you can. and then we'll get to our questions once we've heard from all six of you. mr. nagel. >> good morning, mr. chairman and members of the subcommittee. in addition to being employed in

the trucking industry over 30 years, i grew up and as my late grandfather began after world war ii and ran several trucking companies including his own until retirement. our company, we service most of the top ten food manufacturers as well as the large food distributers in the united states. there are two elements of this proposed hours of service reform that will critically effect the industry; the reduction in the allowable driving hours from 11 to 10 and combined with a 34-hour restart permission that requires two off-duty periods. for our company this effectively reduces our ability to generate revenue by 17% as in our operation our drivers would be limited to working 50 hours a week from the current 60. our cost of operations, fixed costs of $75 an hour with our equipment changing it to this proposed 50 hours, our fixed cost now becomes $90 an hour

with nothing more than the stroke of a pen. fmca states that we note that the proposed rule, so on and so forth, without significantly compromising a driver's ability to do their jobs and earn a living. and i need to ask secretary lahood what his definition of significant is. basically, they're admit nag a driver's -- admitting that a drive's ability to earn an income will be compromised. our truck payments, our drivers' wages, our insurance costs and all the associated costs of business don't go down just because our ability to produce revenue has been restricted. the current proposal is effectively influenced by the teamster union ltl daytime-only drivers. that represents 10% of the industry work force, and by placing great emphasis on the studies that are essentially based on an irrelevant percentage of the entire trucking industry is a smoke screen. it is an illusion that was being

proposed will be a one-fit-for-all solution for an industry that is safer today than at any time in recorded history. in order for our company just to break even the with all the proposed constraints, we would need to raise our rates about 20%. they'll have a serious hyperinflationary consequence on our economy, and households will be suffering the most. since 2003 there's really been no -- excuse me. since 1938 there has been no substantive changes in the hours of service. since 2003 this will be the fifth proposed change. what has occurred in our industry over the last eight years requiring so many legislative actions? sadly, those of us who eat, sleep, breathe and live transportation feel that politics is becoming the pulse of our industry and not pragmatic supply-chain solutions. since 2003 there's been a 33% drop in truck-related fatalities

as well as a 40% drop in truck-related injuries. not only on a percentage basis, but on a per million mile basis it's been senately reduced. our company is an irregular route carrier meaning we have no predictability in our scheduled rate. drivers are unplanned and totally out of their control. we have lost a very important provision starting in 2003 in eliminating in its entirety in 2005 which is the split sleeper berth provision, one fundamental provision that gave our drivers the flexibility to comply with hours of service in the areas in which they get involved in unpredictable and out-of-control situations. the receivers will not let us drop, you know, our equipment stay there for ten hours, and we're being forced at times to run illegally because of route hours until we get to a safe haven. as an industry, we are asking

that even though fmcsa acknowledges the lack of available rest areas, provide us the opportunity and the drivers to remain legal with the flexibility of finding a place that can accommodate them comfortably. so in summary, please, keep the 11-hour driving rule, maintain the current 34-hour restart provision that would not include two consecutive midnight to 6 a.m. off duty, and if we can continue to get that sleeper berth provision, that would be a tremendous benefit to the industry. thank you very much and best wishes to you and your families for the holiday season. >> thank you, mr. nagel. mr. keysaw. >> mr. chairman and members of the subcommittee, my name is glenn keysaw, i'm the director of transportation and logistics for associated food stores base inside salt lake city, utah. associated a retail cooperative founded in 1940, a privately-held company that provides grocery products and

services to about 800 privately owned services in western states. thank you for inviting me today. today's hearing on bending hours of service rules. my testimony's presented on behalf of associated food stores and the food marketing institute which represents retail supermarkets and food wholesalers throughout the united states. i plan to summarize and ask that my entire written testimony attachments be made part of the record. mr. chairman, associated foods strongly support it is current hours of service regulations. we do not propose the new rules being proposed by the department of transportation for the following important reasons. the hours of service rules will not be good for the grocery store industry as they will not be good for my company and, in particular, our truck drivers. if d.o.t. decides to finalize this rulemaking, it'll adversely effect my company in terms of costs. i've done a quick economic estimate on the proposed rules to our far west warehouse. under the hos proposal, if we're

to maintain the same level of service to our accounts, we will need to make a capital investment in $1.7 million for new equipment, namely tractors and trailers. a tractor with a sleeping compartment costs about $160,000. benefits for additional drivers totaling more than $200,000 annually. in this regard, i'm very worried that we won't have enough qualified drivers available to fill our future needs under the new hos rules. i should mention that since the inception of the current hos rules, associated's truck fleet has traveled 52 million miles. during this time we've had eight recordable d.o.t. accidents. in addition, associated has not had a single inspection resulting in our equipment or drivers being put out of service. we're proud of our safety record

and don't want to see changes that might negatively impact it. our company will also incur additional fuel and may maintene costs as well as miscellaneous fixed costs. our warehouse would be well over $2 million. for an industry that operates on a profit margin of 1%, any new costs will be felt immediately. earlier, i mentioned that d.o.t. rulemaking will be good for our truck drivers. with this reduced drive time, it will mean more layover time for them. drivers unable to go home and be with their families. this won't be the case under the hours of service proposal. this means our drivers' quality of life will suffer. i have a letter from one of our drivers who traditionally does a route to twin falls, idaho, that i'd like to enter into the record. the reason he likes this route is he gets to spend the night at home with his family, but under the new rules, he'll have to

sleep in his truck two to three nights a week. consumers, unfortunately, will be paying more for groceries because our transportation costs will increase. the proposed rules will also mean increased transportation costs for all agriculture-related sectors from farmers all the way to retail. sadly, consumers will be hurt most in terms of how much they'll be paying for their groceries because of this rulemaking. with the current economic recession, we can't afford any unnecessary cost of regulations such as the new hours of service proposal. especially the 14 million americans who are unemployed, the millions of seniors living on fixed incomes and for those comment on domestic feeding programs such as wic whose benefits won't buy as much when food prices go up. it's difficult to project how much the proposed hours of service rules will ultimately cost consumers, but we know there will be increased costs that, unfortunately, will have to be passed along.

to conclude, we believe the current hours of service rules are working well, and we see no quantifiable reason to change them. the rules on the books are easily understood, they're promoting safety and compliance. over the past seven years, fatalities and injuries are down by more than one-third. as a matter of fact, fatality and injury statistics are at the lowest levels even though the number of miles driven is increasing. our industry strongly supports the current hours of service framework, and it should be retained. thanks for allowing me to participate. >> thank you, mr. keysaw. mr. mac kick, e. >> mr. chairman, members of the subcommittee, my name is rob mackie, and i'm the president and ceo of the american bakers association, aba advocates on behalf of the $102 billion baking industry employing 630,000 skilled employees and more than 700 baking and supplier facilities around the country. awa members -- aba members

produce bread, rolls, to tortils and nutritious products. the wholesale baking industry currently corporates the fourth biggest commercial trucking industry. aba greatly appreciates this opportunity to provide its perspective on the federal motor carrier safety administration's hours of services regulations. the majority of members utilize their own fleets of vehicles for the interstate distribution of baked goods to their customers. the industry views itself as bakers and not as trucking companies. driving is incidental to the true function of route sales representatives which is sales and customer service. the wholesale baking industry makes its living on delivering the freshest possible product to grocery stores and restaurants. in addition to the safety of the industry's employees and the public, the idea of a truck with a company or family name on the side of it involved in a traffic accident is a huge incentive to operate in a safe manner.

the nature of many bakers' distribution systems involve operators making repeated and sometimes lengthy stops during the course of their workday. route sales representatives may make a couple dozen stops in a single day. they spend more than half of their time in nondriving activities; servicing the customer, stocking shelves or in-store marketing activities. the rule at the heart of today's hearing marks the fourth major rewrite of in the regulation by fmcsa in the past 12 years. the current hours of service regulations have been effective in improving safety as demonstrated by the current crash data trends. the safety performance of trucks has improved at unprecedented rates under the current hours of service regulations. the number of fatal accidents and injuries involving large trucks have declined by more than a third to historically low levels. given these facts, we find it difficult to understand the rationale for added regulation,

especially one that even fmcsa recognizes would disproportionately and negativive impact the short haul segment of the trucking industry of which bakers are a part. typically, d.o.t. has treated the vehicles that our industry operates similarly, each though you can see they're different vehicles, indeed. the relative costs and benefits differ considerably between the long haul and short haul segments. most of the costs arise on the short haul segment, but all of the purported benefits come from reducing long haul crashes. fatigue-related crashes are considerably less common where the operator is typically returning home at the end of their workday. fmcsa crash data indicates vehicles less than 26,000 pounds account for 52 president of registers trucks but account for 10% of fatal accidents and 14% of nonfatal accidents.

clearly, any fatality is too many, but logic and cost benefit analysis dictates that any regulatory effort be proportional to the risk. another undue burden would be created by the proposed change in the 34-hour restart provision requiring drivers to rest a minimum of two consecutive, complete nights. ed this do little to promote driver safety in short haul operations. a typical route sales representative will not have two consecutive days off as bakeries are down on tuesdays and sundays. also, most deliveries by bakers take place in the early morning, the very hours required by the rule that they be at rest. to insure that local grocery store shelves are well stocked with the freshest possible product for customers. many baked goods have four to five days of shelf life making timely delivery critical. the change to the 34-hour restart provision outlined in the rule could also require short haul operators to deploy more equipment and resources

during peak commuter driving hours. this could adversely impact safety and air emissions while also negatively impacting productivity for both the drivers and the customers. this may result in lost sales as well as production delays. if the new hours of service regulations become effective, it will be more difficult and costly to deliver products, increase traffic during the most congested times of the day. in conclusion, there is little safety benefit or rationale to change the existing rules. again, the proposal would require significant changes to baking industry distribution systems, would impact employee work hours and increase the cost of delivering fresh bakery products. ultimately, the consumer will feel these costs at the checkout aisle. with the high unemployment and high food inflation, now is the worst time to be pushing regulation for regulation's sake. aba appreciates this opportunity to provide input to the

subcommittee and be happy to answer any questions. thank you. >> thank you. mr. miller. >> chairman jordan, members of the subcommittee, my name is frank miller, and i'm the director of logistics for the babcock corporation. thank you very much for the opportunity to be here today to testify. today i will testify on behalf of ws babcock corporation and the national retail federation. ..

>> as the world's largest retail trade association and the association and a voiceover to trade a worldwide, and are ever present retailers of all types and sizes including chain restaurants, industry partners from the united states and more than 45 countries abroad. retailers operate more than 3.6 million u.s. establishments, or one in four u.s. jobs. for 2 million working americans. contributing 2.5 trillion to annual gdp retail is truly the daily barometer for the nation's economy. that cox transportation networks consist of more than 45 tractor-trailers which run more than 4 million miles annually in eight southeast states and a fleet of delivery trucks operating from badcock stores to the customers homes.

in addition, badcock tennis more than $3 million in freight annually with us-based common carriers. we estimate the proposed change in hours of service rules could increase transportation costs for badcock by 10 to 20% annually. for badcock this would result in an estimated increase of approximately 2.8 million annually. we are also concerned about the possibility for adverse unintended consequences as a result of the proposed changes that could lead to further increases in cost. for badcock a reduction in driving time from 11 hours to 10 hours would affect an estimated 11% of loads resulting in an approximate cost of $1.5 million. forced the company to increase driver compensation to retrain -- retain drivers, pay higher rates for trucking. the changes to the 34 our restore could affect an

estimated 6.6% of badcock loads a year resulting in an additional annual cost of $940,000. those common carriers utilized by the company would most certainly also be impacted by the change. we feel the changes will result in more flaws carry a productivity that will be passed directly to the consumer as millions of dollars in rate increases. in addition it is important to note distribution networks are experiencing increased demand which is expected to grow substantially. the significant -- additional trucks and drivers will be necessary to meet this growing demand regardless of the hours of service requirements, adding new capacity will be extra me difficult as there is currently a shortage of available safe qualified drivers. we are also concerned about the potential adverse impact on road and highway safety, and on many environmental investments and the supply chain. the proposed changes to the hours of service rules may increase the number of trucks to

move the same freight while restricting the ability to move a portion of this freight during non-peak commuting hours. in the transportation sector many retailers are actively pursuing strategies to greatly reduce their carbon footprint of the supply chain. many of these initiatives to deploy trucks productively as possible during nighttime hours. to conclude, on behalf of ws badcock corporation and national retail federation, i can like to thank for this opportunity to testify during today's hearings. no, half of america's retailers, we urge the train came to maintain the current hours of regulation which are working but i look forward to answering any questions the members of the tree may have. thank you. >> mr. jasmine. >> good morning, chairman jordan, ranking member kucinich, and members of the subcommittee. on military affairs and thank you for inviting me to testify today. i am henry jasny, vice president

and general counsel for advocates were highway and auto safety, a nonprofit coalition of public health, safety comes consumer groups and ensures dedicated to advancing highway safety. we have worked on truck safety issues and driver fatigue in particular for 20 years, participate in national summits, hours of service regulatory docket, which we have borrowed many comments on, and litigation has been ongoing. truck crashes are serious and deadly problem to kill thousands and injure tens of thousands people each year. even with the recent decline in march truck crashes, or 3380 people were killed and 73,000 injured in 2009. this is equivalent to major airplane crash every other week of the year. the annual cost to society remains over $40 billion. to put a face to the statistics, i know that mr. slaughter was introduced and his son earlier by ranking member kucinich, also in the audience is marsha woods

who lost her college-age daughter and her friend to a crash in 2002. crashes involving truck driver fatigue kills as many as five and people a year, but the actual number we think maybe twice that figure. we think that this shopping christmas season consumers will want to know that when they go to pick up their bargains, that they can return home safely without running into a tired trucker. the research and science supports reform of the hos will. studies have found that since the current hos rule went into effect, large number that truckers admit to falling asleep behind the wheel while operating commercial vehicles that went to 80,000 pounds. we saw one site assisted six regarding nearly half of the truckers who were polled in 2006, half -- after this current row went into effect they said they thought asleep at least once part to the role. practically wearing the driver fatigue remains a major safety problem it needs be addressed by

changing the rules. 2003 final rule on which the current rules are based, contradicts the scientific research and evidence regarding the fmcsa's own findings of fact. the basic principles are straightforward. driving and working long hours causes fatigue as shown in truck crash data. crash risk increases geometrically after the eighth consecutive hour of driving a truck. driving during the 11th consecutive hour exposes both drivers in the public to an additional hour of danger when the crash risk is at its highest level. allowing only 34 hours off duty instead of taking more time for rest and recovery as was allowed in the prior rule before 2004, resulting punitive fatigue due to lack of sufficient to lead. finally, truck drivers need between seven and eight hours of sleep each night between ships to be alert while driving. fmcsa found that less -- since

the current hos rule violates those basic principles of science, it is fundamentally flawed and needs to be revised. furthermore, claims that there is no safety problem under the current rules or the current rules intended to safety are false your i have no scientific support and the basis of fact. they are literally junk science. legal decisions also support reform of the hos rule. the two unanimous decisions of u.s. court of appeals have vacated the rule reinforce the view that the current rule is unsafe and needs to be reform. the initial decision held the lack of analysis of the driver health issue was fatal to the rule. the court went on to point out that many legal deficiency in the agency's reasoning abounded. among them the core question legal sufficiency of the agencies justification to the 11 hour limit, not addressing punitive fatigue resulting from the short 34 hour restart provision. the judge wrote that initial

opinion was not made to the federal court bench by senator jesse helms. the court, cost reform of the. not reform the hours of service rules will cost consumers and taxpayers billions of dollars in deaths, injuries and crash cost us was driver health costs and shorten lifespans. the benefits to society of the options supported by advocates for the 10 hour rule far outweigh the cost and result in an economic benefit to the country of between 380 million, and 1.2 million annually from reduce impacts on driver health coupled with prevention of numerous deaths and injuries and crashes. the reform option also support by advocates also would create 40,000 new driver jobs. this is a major benefit to society for job creation. this is in stark contrast to the current hos rule which eliminated nearly 50,000 jobs since it took effect 2004. unfortunately, not all companies

have good safety records like mr. keysaw's compass of the need to be governed by regulations that will keep them in line. and, finally, in closing i would like to say that the edgeworth announces that you've introduced to the record recommends that there be no calculation for driver health and safety costs, medical costs. and we think that's an unreasonable position and that if that was adopted by the agency, that that would build in an arbitrary and capricious argument is the rule goes up on review to the court once again. with that, mr. chairman, i would like to introduce my written statement to the record. i would also ask -- i would like to submit that to the record and no direct answer any answer any questions. >> without objection. anti. let me also express on behalf of the chair and the committee our condolences to the wood family. thank you for being here today. dr. david. >> thank you. mr. chairman, members of the

subcommittee, i'm an economist and a vice president at edgeworth economics, a consulting firm here is in washington. i have a ph.d with specialization in public finance and in my mental economics and 15 years of experience in regulatory policy evaluation. i was retained, my firm was retained by the ata to analyze the cost-benefit calculations and if fmcsa's ir day, my report folks on whether the's methods are accurate and consistent with current data and compares the agency's approach to the approach taken in previous our ace. to summarize, the proposal to restrict driving time to 10 hours a day from the current limit of 11 hours, fmcsa as was lost but to the cost of about 1 billion per year, and benefits of about 1.4 billion per year related to reduce crashes and improve the driver health. so the net benefits estimate by

the agency for that option are about 380 million per year. to obtain these results fmcsa made several changes to the previous approaches used in previous tranninety i find in every incident the new methods increase the purported benefits of the proposed rule. however, many of these new approaches to supply a simple data use outdated information or lack support antarctica and i'll describe your three of the most significant issues. first fmcsa uses of data every our large truck crushed accessible troll rule, i really this is a key input to the analysis. fmcsa uses a figure of 434,000 crashes per year which is approximately of crashes 10 years ago before the current hos rules were implemented. large truck crashes however have fallen steadily since then it recently falling to 286002009, that's 34% lower than the agencies figure. i'll note that decline was occurring before as well as

during the current economic downturn, as you can see from a chart which i attached to my testimony. fmcsa's use of old data inputs the benefits of proposed rule by about 250 million per year. a second issue relates to fmcsa's calculation of the fraction of crashes caused by driver fatigue. obviously this is another critical assumption since the proposal would affect on those types of crashes. in the 2007 riaa, fmcsa contributed to go to factor in about 7% of crash. agency now uses different methods and data in particular comes to become in particular the large truck crash causation study and check let's figure out twice as high, 13%. however, the agency's new method is flawed. fmcsa inappropriately assumes each associate factor identified in the report was the cause of the crash, even if multiple factors were present. so for example, suppose

investigators identified three associated factors for a crash, particular crash, prescription drug use, speeding and fatigue. the agency assumes a limiting only driver fatigue would've caused that crash to be avoided. this method contradicts fmcsa's own conclusions and ltc c. s. report when and not aged factor should not be considered to represent an independent cause of the crash. increasing the assumes crashes caused by fatigue from 7% in the previous in play to benefits of proposed rule by $330 million per year. a third issue relates to the benefits of increased sleep time for driver health. previously fmcsa concluded that existing rules did not adversely affect driver health. the agency now have over and include substantial health benefits council increases in sleeptime within the normal range of six to eight hours but, in fact, agree to fmcsa about half the total benefits of the

rule would come from this rather than from reduce crashes. one problem with fmcsa is approach relates to the application results from a study by ferry, a sleep researcher, very measured mortality rates for a cohort of british civil servant in the '90s reported sleep levels in the categories of five hours or less, six, seven, eight and nine hours or more. while there he did find increase would have soc with the lowest and highest sleep levels, the researchers found those assisted significant differences between the mortality rates people report between six and eight hours of sleep. of academic research confirms this conclusion. for example, do without is no evidence that sleeping a bit children six and eight hours per day is associate with harm in long-term health consequences. fmcsa cites the study but ignores is defined to understand the professor has submitted a report into this docket stating that the agency misinterpreted his research and to support its conclusions. fmcsa's unsupported assumptions

about reduce driver mortality inflicted benefits of the proposed rule by $690 million annually. in addition to these three issues there are other unsupported assertions and that the logical errors which further inflated. benefits of the proposed rule. if these problems are corrected, i find the new rule would result in a net cost of about $320 million annually, rather than in the benefit of 380 million as calculated by the fmcsa. i know that mr. jasny stated that we had a recommendation that the new rule not include benefits from improved driver health. that's certainly not my position. i just believe the calculation should be done based on most accurate and best available data. i thank you for your time and i encourage you to read my report for additional information. >> thank you, doctor. let me start with you, this new proposal would create 40,000 jobs and we just heard from four witnesses.

the first witnesses that will cost them more money, this new rule. yet mr. jesse says it will create more jobs but as an economist what's your take on what may happen with the new rule? >> well, the good still have to be transported, so under the contents of such of the drives are now driving are going to drive fewer hours. those hours would need to be replaced but i assume that their income would go down and possibly someone else's income would go up, perhaps there would be some new drivers. i think the overall amount of driving probably wouldn't change that much. >> okay. let me come to mr. mackey. it seems to me the current rules are working. we have the safety numbers have been good. that's what increase miles. we have seen increased truck you mouse over the last decade. is the current rule working in your estimation just the way it is supposed to? >> its survey not perfect as it applies to short haul and we

continue to work with d.o.t. on issues around the edges. by and large it works in the data as we are today it clearly illustrates a. it's a pre-substantial reduction, 33, 34% reduction in those accidents involving trucks. so seems to be working pretty well spent would you also agree there's the potential at least if the new rule is put in place that we could see him potentially more accidents? we could see a harm to the safety record, because as an mr. david just talked about that one of the more drivers on the road. my understanding is what would work as well, it would potentially more drivers on the road during the daytime hours when there's also more just people, non-truck drivers out doing shopping, going to work, doing the things they do. is that a fair assessment? >> it absolutely is. i think you get few to cover those additional hours. frankly, to be on the margin of safety and air so they don't run

the risk of going over the reduced hours that would be available. similarly particularly in our industry as mr. key saw can testify to come we're delivering products in the early morning hours so that when a customer walks in historic, they have fresh bread. and so you're going to push those into the daytime hours and it will be -- >> what about the midnight rule quick to think is also the potential would like to not think this but also possibly the potential that some drivers may want to drive a little faster to beat that deadline? >> i think that is, i don't have any data to back that up but clearly, they will want to get thompson spent i assume they may want to increase the means increased chances of accident increased to harm spent absolutely. >> it seems to me the current rule is working. there's a safety concerns under the new rule, and as we have heard from the first four witnesses, all this is going to create more cost. and i would still argue that the

idea will have more jobs, basically economics is okay, what's pathetic savio is getting economics class. to klesko break and let windows will have to hire more people to come fix the windows but we create job at it that really add to the oval economy them and welcome at what would have happened in oregon. i would argue this is in some ways moving in that direction but that doesn't make sense to me. mr. nagle, talk to me about the 34 hour rule to the consecutive nights and what that may mean. it seems me that could be potential because to trucking companies. >> that is potentially a real problem because the fact you may have a driver that gets in after midnight, could be 12:15, 12:30 and have now had to literally go 54 hours to his next available driving time. so he is going to lose an entire day of productivity, alternate

his wage. and the company itself is going to have the same loss of revenue, increasing our fixed costs per hour even further. drivers are going to stay away, home longer. fmcsa states even though they don't have the statutory authority to address the lack of available rest areas and accommodations were truck drivers, it's going to cause these guys are forced these guys to stop in areas where there are no accommodations. they are going to be in shopping mall parking lots. they're going to be just pulled off the road on major highways. they're not going to have rest. essentially forcing a guide to stay 54 hours in an area the size between the top and lower bunks of your children's homes is inhumane and cruel. they're not going to have any restroom facilities. they are not going to be up have any hot food or any of the accommodations.

how somebody can rest better under those conditions is beyond my reasoning. so the quality of life is going to diminish further, and, and for our area of service, we are a regional care that services primary from baltimore, up to portland, maine, it's going, it's going to just reduce our productivity substantially. >> thank you, mr. nagle. my time is up. i will yield to the reagan everett. >> thank you, mr. chairman. you know, since the debate here is really monetizing the cost of relations versus monetizing the cost of not having effective our better regulation. i just want to cement for the record to documents, one space to the regulatory impact analysis for the hos proposed rule estimates that's based on a 10 hour workday, monetize safety

benefits and drive health improvement benefits range from below 300 million to more than 2.4 billion in quantifiable benefits from reduced crash and benefits cost, lower medical and health payments, and longer, healthier driver life expectancy. one of, you know, you can't just talk about the cost of regulation which without looking at the fact is, if you don't have the extra costs in these crashes. how do you monetize the cost going beyond that to the wood family? you know, actually juries do which is one of the reasons why the insurance institute of highway safety filed the research arm of the injured, filed a lawsuit that supports the problems of 50. and there are insurance there are insurance companies that are members of advocates for auto and i was safety, they support reducing fatigue. if we are going to have a

hearing on the costs, and i think it's a legitimate question. what other costs? but you've got to weigh it in terms of what are the cost to society. on the other side to give you don't do both you don't really get a fair reading. now, mr. nagle, i want to ask you a question about a company that my staff has identified. my staff found that nagel toledo inc. which is less on the federal motor safety care, safety measurement system as d.o.t. 423609. you are here as the ceo of the nagle companies. i have a copy of the bio that was omitted to this committee that goes over your involvement in the industry, and has useu of nagle companies, and it also lists niggle toledo inc. as one of the companies that you become is that correct? >> yes, sir, it is.

>> i want to discuss something with you. because the federal motor carrier safety administration's compliance review, which i have a copy of your, of nagel toledo reviews, or reveals serious hours of service and other safety violations. now, according to the federal motor carrier safety administration, nagel toledo has received 12 unsafe driving violations within the past year, and 23 over the past two years. now, is the information accurate? >> that is correct. >> and the motor carrier safety management system also shows that nagel toledo has received 13 fatigued driving violations within the past year, 32 over the past two years, and the past year, nine of the 13 violations resulted in and out of service order, including seven violations for requiring or permitting the driver to drive after 14 hours on duty, one full

support of drivers record duty status, and one violation for requiring or permitting the driver to drive more than 11 hours. is this information that was given to the government, is that correct? >> that is correct spent is also true that nagel toledo has been involved in to department of transportation report truck crashes over the past year, and five in the past two years, is that correct? >> i would have to defer, the report is probably correct. >> let me ask you this. i understand your of those to going back to the 10 hour limit on consecutive driving, but help us in this committee, in terms of your own experience, your own experience, how is that practical and how, how can i take your testimony, based on the record that is in your, you

know, help me square the record that is in your with your testimony, mr. nagle, please. >> thank you for those points but i'm glad to address the issue. first of all, the step that the csa enforcement, we also did the same with internal controls. what the report doesn't take is there were seven or eight offenders during that time period. prior to that audit we had fired four or five of those individuals, because of those violations. and that was prior to the audit. another two or three word on your final warning, and has since been terminated before we even received that report back from -- we take it graciously. spent listen, i imagine him you're running a company community take it seriously because there is a bottom line. you have to be insured -- concerned about your insurance

cause. you have workers are putting in all these more hours. don't have some concern that they might be working too many hours and it make your company vulnerable if not just her company, unicode people in the larger community? coach of concern about that at all? >> i have a tremendous concern about that. in fact, i personally spend time educating the general public about sharing the road, and also communicating to them that our drivers are not just these killer trucks that some of the people tried to portray. it's more than just a cost-benefit analysis, okay? i have a moral obligation to make sure that our drivers operate in a safe fashion. now, part of issues that came up, fatigue is probably one of the most misnamed things. and several of those were literally a clerical error where the driver miss added his hours of service. but more importantly, with the

sleeper berth issue that i've mentioned briefly before, and it's in my written report, when one of our drivers will go into an area, heavily populated, we get detained above beyond the hours of service. well, they are not allowed to stay in a customer in brooklyn, or whatever the place may be. we are forced at times to appear at a time to drive illegally to go to a safe haven. so i would say half of those violations have occurred over the last -- >> i appreciate your indulgence in giving the witness time to respond because i know that expand the time that ahead. i just want to add this if i make with the chairs intelligence. -- indulgence. you got rid of some of these employees. the only point i'm making, mr. chairman, i want to thank you

for being fair here, and that is that it's important to hear from mr. nagle, but look, there are issues of the teacher that we can't gloss over. that's my point. you know, i didn't rip you apart for this record. you know, we can do dramatic here but i'm not interested in the. i just want to point out that this issue is a legitimate issue of driver fatigue. thank you, mr. chairman. >> mr. keysaw, -- [inaudible] >> know. spent mr. mackie, do you? >> absolute not spent mr. miller, to you? >> absolutely not. >> because it is in your best interest for the well being, for the profitability of your company. in fact, i would assume many of the trucks that are on the road, you probably have the site i've seen come if you don't like my driver, call this number. you have some of those signs on your truck? >> absolutely. >> mr. keysaw?

mr. miller? >> no, but we are in the process. >> i assume the reasons mr. mackie that you have those because you probably get some benefit from insurance wise, insurance payments. you just want the public to know if your companies name is on the trade of the truck, you have safe drivers. there's market forces involved in safe records as well, right? >> there's clearly an economic benefit but clearly these drivers, particularly in our industry, 20, 25 year employees so there's a family connection as well. we don't want these people to get hurt. >> and mr. nagle understands the concerns because when you drivers who were not followed the rules he got rid of him because he extends that's the best interest of the safety but also the best interest of his company, correct, mr. nagle? >> that would be correct spent i yield to to the full committee -- the member to the full committee. >> i appreciate the indulgence. i'll go to the same for folks. with all due respect to the last two witnesses.

i really think this is about people who actually operate trucking fleets here today, and what is the practical implication. i know that numbers are not supported based on past arithmetic. i know that the numbers are supported slightly based on current arithmetic. but let's go through some of the arithmetic and how it impacts you. mr. nagle, i'll start with you since you record was called into question. hopefully those signs on your trucks say, and please don't call while driving because you're going to be distracted as a car driver following that truck. the number one issue of the department of transportation over all cabinet officer ray lahood is, in fact, distracted driving. isn't that as much a part of the problem that accidents and problems, and even, that you drivers receive from have a lot to do with their lack of focus? not necessary how long they've been up but a lack of focus. isn't that one of the major

points you look for in your driver's? >> one of the things we found out is typically it's not because of a distraction. when they are stopped, increased enforcement. they will use another reason to check your drivers logs for stopping but it could be a marker like it is out. the driver could be going three-mile an hour over the speed limit. so the fatigue factor or logbook factors have not been the reasons for the stuff but it's been for something else. >> mr. keysaw, and i've had the opportunity of driving large rigs in mike white distance past, including more buses and trucks but my father had a trucking company, truck repair company primarily. the one thing i find interesting about particularly largely drivers is that their ability to be employed depends on the record is no question at all. uses a record, you lose your employability. but just the other thing i always question.

in your experience, the forget as operators or overseers of operations, is there anything in these new regulations that is going to ensure eight hours of restful sleep? anything? are you all familiar with the crash in buffalo in which two pilots were so tired from having flown across the country and then got on a plane and being up for endless hours can even though the actual today was only a couple of hours when you look at the ice building up on the wings and apparently were so tired that they couldn't figure out that you're going to crash? now, faa has regulations about sleep. there actually are regulations. they have tried to great regulations about duty day but they're the same problem that you have. nothing in this regulation, and i saw all positive heads nodding, nothing in this radiation is going to guarantee that the driver goes to bed and stays in bed and sleeps well for

eight hours. if we're not actually guaranteeing rest, the last two witnesses that talk about these studies and what they showed, doesn't mean a darn thing. if you sleep apnea you could be off the road for 54 hours and come back just as incapable of being a good driver. now, for the fourth of operators and many of you have fired people for drinking within the window of their driving can either just before, during or after? all of you question of all fired people for drinking. same question. is anything in this regulation going to know that when they leave work for the prescribed period of time that they're not just going to the bar? so, you can come back, tired with a hangover, having actually driven for maybe six or eight or 10 hours, to go see mom in upstate michigan from toledo, and you come back and you met all the requirements of this new regulation but, in fact, you're not fit for the next 10 or 11

hours, is that you? >> would the gentleman yield? >> not yet. >> is there anyone that knows of anything in this regulation that will ensure that your action have rested drivers versus ensure that your drivers are simply available for duty, about 10% less time? i would yield to the gentleman from ohio. >> i want to thank my friend for doing that. we are not really here to talk about whether drivers go to bars, or drink at home. that's not the point. the bottom line here is who's running the business? not the drivers. you are a businessman. i respect that about you. you bring a dimension to this congress because you understand business. a truck driver wasn't calling the shots. he had a contract. that is something to do with it. >> reclaiming my time. are any of you aware of a study that shows that the duty day in

the 11th hour, or the 10th of our actually into the 11th cut off, that during that time there is a significant admission of capability? in other words, for any of you, and dr. david, i actually go to pick you've looked at these studies. these studies are about how long you sleep. if you were to, from the economic material he reviewed, if you were to give the risk of the 11th hour, assuming that you got a good nights sleep, that you're well rested, confident, not distracted, and sober and having been sober let's say from a previous 24 hours, was there anything that would tell the actual risk of the 11th hour was? and if so, was it scored? >> i think the studies show the risk of the fatigue related accidents does increase. i think the issue is how many of those are there and how many would be reduced by this regulation. >> exactly. if you were to score just the

11th hour, if you will, the difference between 10 and 11. if you were to score that what would the accident ratio and/or cost me in isolation? because as i see it, this is a study that supports this regulation, you have to throw in the card, the horse, the buggy, the with and everything to get slightly into a positive ration of the cost benefit, isn't that true? >> i found that the ratio was negative using the best available in those current availability. and they note the only way you can get to that negative is by including the issues related to driver health not just the crass issue. if you just look at the number of crashes i think fmcsa would agree under their own analysis the answer would be into negative territory. >> last question. very quickly. isn't it true that more crashes occur in the first part of a shift in the last part? that drivers actually had a poor record in the first four or five hours than they do in their last

four or five hours? mr. nagle come you been picked up and when did these crashes occur? >> typically in the first four hours of the on duty status. >> so real world, dirty finger knows can you do the job, you look at these people. the fact is you're more concerned about him going out not rested in his first four hours in the last hour days on real world experience? thank you. thank you, mr. chairman. >> the gentleman from -- >> mr. chairman, i have a response. quickly. for one thing, crashes in the 11th hour, while they are not as numerous as in earlier out, that's only because most drivers are driving the first eight hours, not all drivers are driving the 11th hour. but the risk, the rate of crash is much higher in the 11th hour. that's been shown. that's statistically -- >> will you make that a fable, the studies for the record? >> absolutely. >> without objection, there's a

research report study showing adverse health and safety effects of longer working hours. without objection i would like to submit the. >> i appreciate that although i didn't quite hit the last part. you said and inadequate rest spent longer working hours and inadequate best time shows and actors health and safety effects. this is from advocates for highway and auto safety. >> mr. chairman, although i don't disagree with unanimous consent, i do wanted to be noted for the record that the combining of long work hours and inadequate rest makes a different point than the actual period of time that you work. inadequate rest is something i think we're all here wanted to forget how you would get. speak without objection. the gentleman from iowa is recognize spent let me start by asking the panel, how many of you have actually works as a licensed truck driver in your lives? any of you? i have. and i can tell you from personal experience that the level of stress on a truck driver goes up

in direct proportion to what's going on in the workplace environment. if you're hauling grain during harvest season in iowa you have to thought more stress on you than you do if you're hauling it on a summer day. and one of the concerns i have is that we are really talking about two different things here today. the first four witnesses on the panel called by the majority are making a common point, which is that the rules that are being proposed are bad for business. you all agree with that point, don't you? okay. will, in an ideal world, the best rule for business would be no hours of service limitation, where you were free to set your own timeframe. and get your shake your head, mr. nagle, because you know there's a problem with that. because there are back side costs, liability costs that will come if we don't have some reasonable restriction on hours of duty. is that correct? so what we're really arguing about is whether the rules that

has been proposed or the rule that is in place make more sense for the purpose that his agency was set up to address it and if you look at that purpose, it is not called a federal motor carrier profits administration. it's called the federal motor carrier safety administration, and it's to set up the rules of the road they give people a level playing field that protect both the interest of the people who want to haul commerce across the road of this country, which i was proud to do, and also protect the consumers who use that same highway, and it may not be involved in a system. mr. miller, you made a point that one of the problems facing the industry, which i am acutely aware of, is the shortage of qualified safe drivers to do your members saying that? is what i don't understand that we are in a recession and. there are a lot of people looking for work. 9% unemployment in this country. why is the industry not able to

find enough qualified safe drivers, if that is the case? >> sir, i don't have a good explanation for you. i can tell you that we are a premium driving operation. we operate a safe legal fleet. we very rarely bumpy 11 hours your however i go to an average of 500 applications to put a qualified driver in my truck, and that's my concern, that people will be forced to put drivers that are not qualified and that are unsafe on the road. >> and that's my point. i'm as sympathetic as you can believe it one of the problems is that there is a huge shortage of qualified drivers, and i think economists would tell us that perhaps one of the reasons for the shortage is that people looking for work do not find in the workplace conditions the pay worth the risk of trying to become qualified to drive a truck, which i think is an honorable and noble occupation.

and one i was proud to be a part of. but if we're looking at one of the reasons that may be contribute to that, i would argue it could have something to do with the hours of service requirement. and one of the things we know, mr. jazzing and dr. david, is this isn't unique to the trucking industry. we've seen this same issue come up in resident physician duty hours, as people have become concerned that patient safety is being compromised by forcing resident physicians to work long hours without appropriate rest and that compromises their ability to do their job effectively, and impacts patient safety. so having heard the testimony today, i would like both of you to respond to the public safety concern and how that relates to the ability to hire qualified safe drivers. >> mr. braley, working conditions are always an important issue. certainly in shift work we've seen that in studies of shift

work all over the world. it's the working conditions. these specific areas if you look at the economists, michael belzer wrote a book called sweatshops on wheels, and he is essentially saying these are the modern-day sweatshops because of those working conditions having to deliver just in time all the time, being under the gun, driving longer hours, and for many noncontract nonunion drivers that are exempt from the standards act. >> dr. david. >> i don't think there's any question that reducing the amount of on tv time would reduce the number of accidents. the question is how much and is it worth it? we have a rule that is more restrictive than the rule used to be. those rules were more restrictive than the rule before that and before that there were not any rules. so the question is, where do you stop and cost benefit is one piece of information you can use to get there. as long as it is done probably. >> and just so i'm clear on one of the principal points of your

testimony, your testimony was that your economic analysis of the trade-offs between the current rule and the proposed rule is there were actual economic benefits to going to the proposed rule? >> well, there would be reduced crashes but that would be increased costs. so i calculated that on net increase cost would out weigh the fight of the reduce crashes. that is sensitive to the assumptions you use, and how restrictive the rule is different of the assumption of the fmcsa uses i can play the cost would be howard -- would be higher. >> the point also made is those costs include opportunity. in other words, that added cost of transportation for these same goods and services could result in new jobs becoming available, taking people off of unemployment, making the taxpayers of this country a less of that burden and having those new employees paying into social scaredy, medicare, state and federal taxes as well.

>> i mean, this will isn't going to be undone when we come out of recession so i would never recommend regulation or solving unemployment problem. but in terms of the number of people actually driving trucks. >> but the point is this is an analysis about the trade-offs between safety on the one hand and with good business requirement on the other hand. and you're always going to have some of those trade-offs. >> that's absolutely true. >> mr. davis community only one who is saying there'll be significant increase in costs. the obama administration itself has said there's going to increase cost with this new rule. >> absolutely. unnumbered -- >> only a handful of rules that said will cost over a million dollars, greg? >> the agency's numbers was about a billion dollars. >> we haven't 9% on the planet, greg? >> as i say, it will continue to be a billion under the assumption. >> thank you. turn out to the gentlelady from

new york. i'm sorry, that's right. the gentleman from tennessee is first. i apologize. doctor. >> thank you, mr. chairman. mr. nagle, can you tell us about the steps your company takes in health insurance driver safety and health? >> i didn't hear the last word. >> can you tell me about the steps your copy takes to help ensure driver safety and health? >> well, i don't know about health. and income we are required to require rigorous physicals and stuff. just our company alone, we do not have the onboard electronic recorders. so when our drivers call in every morning, they have to advise our operations people how much longer they have to drive for the day, when the next 10 our break is up for their sleep. so we schedule pickups and deliveries around that availability of their time and for their sleep. >> let me ask, do you think there is a pressing need for

this rule, or deeply the current rules allow your drivers to balance safety and driver health? >> i think the current rules are a lot better than what is being proposed. i would say that if you can add or bring back in the sleeper berth provision, that would even add additional good rest and solid rest time. >> do you think there's anything else motivating d.o.t. to propose these rules beside safety and health concerns? >> well, there is a tremendous influence from union ltl drivers that they are not impacted at all by the 34 our recent provision. and some of those carriers, well, i would think to be more adversely affected by the 11th 10 our change. but they are taking studies based on a small percentage of drivers that don't represent the typical motor carrier industry and try to broadbrush some of

those regulations over them. so there are definitely other interest that are being represented in this proposal. >> mr. keysaw, i'll ask you the same question. do you think there's anything else motivating d.o.t.? >> i, today the truth, i don't know. i'm not aware of anything. >> okay, that's fair. mr. chancey mejia knows that tracking fatalities and industries -- entries have declined? >> they have, they would have initially the first two years in 2004 and 2005 at the moment into effect it had come down in the last two years but it's been shown that it has nothing to do with the hours of service will itself. >> you acknowledge the number of truck miles has increased since that time? >> yes. >> do you acknowledge registered large trucks have increased since that time? >> it has gone up all the last year and a year before the number of vehicles miles traveled for large trucks or

combination of drugs have gone down. over all the ltl trucks have made up the difference. so it has remained about flat. but for the vehicles that our bump up against the hours of service will most i'm that has gone down last year and the year before. >> based on these facts it would appear 2008 hours have been and continue to be very effective in improving highway safety. is it your essential argued you can never have too much regulation? >> no, not at all. you need to write regulations, and what we have now is not the right regulations for the reasons i stated in the record. they are contradictory of the scientific evidence in the record. they were disputed by the court of appeals as being illogical and of questionable validity. and i'd like to point out that in 2000 there was a notice of proposed rulemaking that actually would have applied different announce service

regimes to different parts of the industry, and congress told agency that they couldn't do that. >> do you believe the regulation should have to lease contribute more benefits to society than cost to society? >> i believe it's clear from the regulatory analysis that these do your. >> okay. driver fatigue can be a cause or factor in any accident, do you agree? >> yes. most crashes or of a factorial incidents. >> are you aware that according to d.o.t.'s own data that driver fatigue does not rank among the most common factors for truck drivers related fatalities? >> yes, but they also underestimate the percentage of the crashes that involve -- >> are you aware of the percentage of fatalities due to passenger vehicle driver fatigue is higher than the truck fatigue, truck driver fatigue? >> i don't know that statistic. >> okay. well, i guess in light of the

fact that there's more fatigue related accidents and deaths with passenger cars, do you think that it should be drivetime restriction on passenger vehicles? >> it's a different operating environment, and those passenger vehicles are regulated by states. they are not regulated, they are not a regulated industry. so it would be difficult to do and it's up to states to do that. >> i think the point is what i'll want to drive a safer highways. the point is what we find a balance in regulation. that's why we're all here but i am at a time. thank you. >> but going back to did 2003 final rule, that in its conception was wrong and we're trying to correct that. we been trying to correct that for the last eight years and save some lives. >> for the record, the truck percentage was 1.4, passengers is 1.7. i yield back. >> i yield myself five minutes.

for the record i would like to submit for the record a statement from the retail industry leaders association, kraft foods, both of express to prevent crashes. but the proposed will fall short of account pushing the goal. without objection. first of all, mr. slattery and mrs. woods had left the room and the chairman has express our sympathies for their losses. but i think as i figure there's not a person in this room, whether you're a republican or democrat, or americans, we want our highways safe. and to think that we don't is really disingenuous. so i think we start with that premise but we all have family members out there and we want them to be safe. but every time a rule or a regulation is pascal or a statute, there's a loss of freedom. so in my mind when we do that we need to justify it. so as i look at these regulations, and i see the

statistics have improved with the current regulations that are in place, i say to myself, why are we taking the steps? what is it that is motivating this? when the statistic, and we all agree, and so much of this job is balanced, balancing safety, balancing our economy and trying to get our economy back on track and being prosperous. so when i look at the numbers, and the statistics, in 1979 there were 7054 fatalities. in 2009 there were 3619 fatalities. almost a 50% decrease. in 1979, there were 0.461 fatalities per 109 miles. and 2009 there were 0.123. almost 75% decrease. so it appears to me that the current regulations are moving in the right direction.

they are making the highways more safer and are becoming safer. the fatalities are down. and in the meantime we are not disadvantaging or creating more of destruction and more regulations for our industry. my first question, mr. jasny, why? why do we want to change something that appears to be working, statistics towards more safe highways is working? >> just as the dow jones goes up during the day, individual stocks may be going the other way. in this case while there are lot of regulations that we have supported and agencies finally come to adopt in recent years that are improving safety and helping, this one is swimming upstream. this one is going against the current. this one is not proved to help with fatigue. the statistics and even the agency said in the nose of proposed rulemaking that there's no connection between the recent downturn which is probably if you look like at my appendix,

the chart that i included from the motor carrier safety administration, shows that crashes are not a result of fatigue but more what are the economic condition of the downturn in vehicles traveled. so there is still somewhere between 501,000 people out there who are dying in crashes involving trucks, and most of the victims in those crashes, 97%, our passenger car victims, people in passenger cars who died. not necessary a truck driver. so there is still about 1000 lives after we think that can be saved by a federal. >> dr. david, would you like to respond to that? >> well, i addressed this question mr. brady brought up earlier, which is clearly restricting hours can have some effect on fatalities and a large truck crashes generally. the question is at what point do you stop. that's a judgment that has to be made based on data.

i mean, there's no question that there could be some improvement of the going is what it is a large improvement or a small one. >> two things. i'm a freshman here, and to things that constantly impressed down here is another one, the disconnect between washington and in particular in this committee, businesses. when we look at these proposed rules i'm always concerned that the stakeholders are not at the table, that the bureaucracies and agencies are making these rules that affect their businesses. date any of you participate or offer up any or have any input into these proposed rules? dr. david, when mr. jasny talked about the court of appeals striking down the last regulation, i'd likely to just to just comment on that. >> i'm sorry, i don't have any opinion about that. >> my understanding is, mr. jasny, do you know why they struck down that regulation?

>> yes. the regulation, the initial decision was struck down because they did not consider the health of the drivers went imposing a rule that would affect drivers. >> so it was procedural rather than -- >> no, it was substantive because it was a statutory mandate to consider that issue him and the agency did not didn't consider the issue. the courts then went on in, all the problems that while the substantive issues regarding safety, regarding the 11 hours, regarding the 34 hours that the court saw as problems when the case came back. >> i don't need to cut you off but my time is running out here and they do want to ask dr. david one more question. dr. david, you mention in your testimony that there were several errors in d.o.t.'s methodology. can you just expand on that for us a little? >> well, there were a number of cases where assumptions were made without any kind of basis.

there were, for example, calculation errors with something as simple as rounding another for no reason can mean a difference of $109 in the regulation. there were several other cases which i outlined in my report. that totaled up to being worth several hundred million dollars per year which could make the difference between a positive benefit and a negative benefit for this rule. ..chair.

mr. nagle, there was some discussion just a few minutes ago with the good gentleman from ohio who i respect very highly. how about your safety record? and it always amazes me -- i'm also a freshman here. and i sit here and we talk about new regulations and we talk about the cost of new regulations, and it always amazes me that there's always testimony that under existing regulations we're catching people who are making mistakes and we're -- as you indicated, you fired a bunch of people who made those mistakes. and yet, we have this administration wanting more and more regulation when it seems like the regulations that are already in place are doing their job. would you comment on that a little bit? it seems like you didn't need

new regulation to, number 1, the people who were penalized. who were penalized under existing regulations and you as a businessman didn't need new regulation to tell you needed to get rid of those people. can you comment on that a little bit? if i'm making any sense at all? >> no. and you are. the regulations as they currently exist, okay -- what had happened is through csa enforcement, the driver's background became much more important and much more public. and so we have to take that into consideration. so at that time, now we place greater emphasis on internal audits and internal logs. and that's where we found a lot of these occurrences. and that's why we got rid of those. but in terms of -- would we have taken those steps knowing that

this proposed regulation were in the forefront, we would have taken those steps regardless. so i really think that just adding additional regulations, additional regulations when less than 2% of the trucking companies have actually been audited and checked, okay? we're doing a poor job enforcing the current regulations on the other 98% of the carriers. >> can you stop right there. that's what frustrates me the most is we have regulators who are not doing their job. we do a poor job with the current regulations and we think that the solution is to add more regulation. instead of just doing our damn job. instead of just doing the things that we should be doing right now we do it in the trucking industry. we do it in every single industry and what we have is an administration that seems like adding more and more regulations we're going to have more safety

when if they just did their job, they just actually enforced the regulations that are already in place, we would have the safety that we need. what do you think about that, mr. mackey? >> well, i would just say to reiterate the point that several of us made is we've been down this road four times in the last 12 years and it's not an issue -- it's not enough regulation. it's hard for companies, again, particularly in our industry, we're bakers first, you know, not trucking companies. we want to know what the rules are and that work for us and instead of changing the rules, moving the goalpost back and forth we've had in the last 12 years, some certainty would be enormously helpful and right now these regulations seem to be working so why don't we stick with them for a while. >> exactly. and it seems like they're working. we're watching the offenders. we're catching the people who are not doing the right job and we have a bunch of egg heads telling us if we do some stupid formula that we're going to have a little bit more safety when i

believe you have your name -- do all of you have your names on your trucks? it's your reputation that is on the line if there's no safety, right? what are the market forces that help you make these decisions? not regulatory forces but market forces? what do you do? is it kesaw? you have your name on your truck? >> yeah, we do. >> so what do you think about every morning -- not the formula that the egg heads are going to give us, but what do you think about every morning when you think about truck safety? >> because we have our name on our trucks, we go about what reputation we have out there to the grocery industry. and, you know, our customers that go into our stores that have the same name on it. we know we're very visible out there. and we want the safest fleet. associated foods have gone down to the extent of putting electronic recorders in their tractors more than a decade ago so that we could have the safest

fleet out there. we also take quality life for the drivers very seriously 'cause we know they're the ones at the end of the day that will make sure that our roads are safe. >> now, do all of you -- i heard -- i think it was mr. miller who said that you're having a hard time finding employers -- employees; is that correct? >> qualified safe drivers, that is correct. >> are all of you having that problem? every single one of you? so who's going to take the additional 40,000 jobs that apparently are going to be created by this regulation if you can't even find enough qualified workers under the existing law? i'm sorry, that's just a rhetorical question. again, egg heads are running this country instead of actual real people who understand what's happening here in america. and how jobs are created and how jobs are destroyed. thank you. >> can i interject a comment? >> certainly. >> one of the concerns that i have in all of the reporting -- when we see fatigue-related

accidents, there is no correlation that at least i've seen as to whether that is a compliance-related accident. in other words, okay, the driver was fatigued but was he fatigued because he was not following the existing laws and violating those laws? the second is a topic of sleep apnea. we're just beginning to explore that topic as well as csa 2010. we haven't even begun to see the benefits of that which is only a year in fruition which is probably the most sweeping comprehensive method that the mcsa has been looking in carriers as well as applying tools to manage our tools in applying the data for us. >> i thank the gentleman from idaho for his good questions. i want to thank our first panel for your great testimony and your willingness to answer the questions and be with us today. we're going to dismiss you now and we'll get to our second panel. so thank you all again.

>> thank you. [inaudible conversations] [inaudible conversations] [inaudible conversations]

[inaudible conversations] >> it's good to have you with us. and we have to do the swearing-in. i'm sorry. you just got started. if you're ready raise your right hand. do you swear or affirm the testimony you're about to give, will be the truth, the whole truth and nothing but the truth? thank you. let the record show the administrator nodded in the affirmative. and it may be just you and me and i guess this will be brief

approximately. but you got your five minutes and if you need more time, go ahead. [inaudible] >> following the pattern of my colleague david strickland and i watched him do the same thing my apologies. thank you for the opportunity to be here today and discuss the fmcsa's efforts to reduce fatigue-related crashes involving trucks to the enhancements of the federal hours rule. we oversee more over 500,000 carriers and millions of drivers with a workforce 80% of which is across the country in the field we are dedicated to our congressionally mandated mission to save lives by reducing crashes involving large trucks. we achieve this mission through a mix of enforcement strategies, rules and tools designed to target our efforts on noncompliant carriers and drivers. we also use research and data analysis to improve overall

industry safety. and our research shows that fatigue remains a significant factor in truck-related crashes. many commercial drivers are still not getting enough rest and breaks under the current rule. last year, 2010, nearly 4,000 people died in crashes involving large trucks. by the department's estimates, approximately 500 of those would have been related to a fatigued driver. each and every life is precious and while it's hard to place a monetary value on human life or families suddenly left without a mother, a father, a child, a friend, a sibling or a colleague, we can estimate the economic cost of commercial motor vehicle crashes. costs include property damage, cargo damage, bridge and road damage, vehicle damage, lost wages, lost productivity, work comp costs, medical insurance, health costs and the list goes on and on. these costs do not discriminate between safety advocate and

small business owner. they impact everybody. in fact, a company with a 2% profit margin would have to earn an additional gross revenue rate of $1.25 million to overcome the cost unexpected, unscheduled cost of a crash that would cost them up to $25,000 in costs not covered through insurance. those are the costs of recovery for a business owner. there is no recovery capacity for a parent to overcome the loss of a child. the purpose of the proposed hours of service rule is to reduce driver fatigue and thus reduce crashes in vehicles. developing this rpm, there was an unprecedented level of transparency and input from all sectors. safety accuracy, small business owners, drivers, shippers, the public at large, large trucking companies, you name it. we began by seeking input from our motor carrier safety advisory committee, a body that

was structured under safety that is made up of representation from law enforcement, from the shipping and trucking industrys, from insurance, basic advocacy communities and labor. using the input from the advisory committee, we set about holding five listening sessions across the country. this is before developing the rules, in order to gain as much input as we could in building the rule itself. the proposed rule. and with the crash data, and driver health and mortality information and thorough economic realities. the nprm was developed using the principles of president obama's executive order which calls for us to use quantative and qualitative cost benefit data, public participation, user participation, and a strong exchange of ideas. because we're still in the nprm stage i'm still limited in how i can respond to some of the questions that may be asked but

please be rest assured that it will be based on careful consideration on all the input we received, the additional data that were submitted to the docket, the draft final rule is currently under review at the omb. so, again, i just want to re-enforce that i speak for all of the fmcsa employees across the country to say we are passionately to our congressionally mandated mission to reduce the crashes of trucks and buses. we work every day 24/7 to fulfill this mission, fulfill the public's expectation for safety and safe travel. our citizens deserve no less. so with that, mr. chairman, i'll be pleased to answer any questions you may have. >> and i'll be as brief as well. you said there were 4,000 fatalities last year. last year you had records because of truck accidents, 4,000 -- >> for 2010, our estimates -- we

continue -- we collect crash data directly from our state and law enforcement partners through our traffic motor advisory program or through our assistance program and through that data preliminarily we're showing an uptick in 2010. crash rates still remain at historic lows which is a tremendous outcome. >> okay. >> not even close to being low enough but that's what we're -- >> so crash rates are at historic lows and you said 4,000 for 2010. >> upwards up. >> what was the -- what was it in 2009? what was it 1995? give me some comparisons. >> so 2009, i want to say 3,360 roughly in truck-involved fatalities. >> that's a definite number. that's a definite number? >> that's our absolute number. >> for 2010 you said it's approximately 4,000. or is that a definite none number. >> that's not a definite number and i say it's approaching 4,000. >> 3300 you gave for 2009 a definite number. what was the definite number in

10 years ago, 12 years. >> it was closer in the high 4,000 range. i don't have that specific number but i'll certainly provide it to the committee. >> okay. and then -- but the trend has been down or is it pretty level? >> the trend -- i think you heard some of the prior witnesses indicate there's been roughly a 30% decline in truck-related fatalities. >> okay. >> we're still upwards of 75,000 injury related crashes. >> and what's that number like. is it the same -- >> that also has declined which is very positive. >> and you mentioned 500 related to fatigue. >> yes. >> and how do you determine that? >> based on our -- our estimates of fatigue-related crashes which we feel is an underestimate derived from our large truck causation study which shows approximately 13% of fatal truck crashes attributed to fatigue. >> okay. and under the new rule, what

does your modeling suggest will be the number -- the overall fatality number and the number tribu attributable to fatigue. >> i've heard a lot of talk from the prior witnesses. we've got costs, we've got benefits. we've got -- without the rule, we've got costs today that we estimate are approach $1.4 billion in cost to society as a whole in crashes and driver mortality, as in health. what we propose under this rule and, again, there are two options in the rule we proposed. we identified benefits that include a reduction in deaths directly under the ten-hour option of approximately 49. and under the 11-hour option, i want to say it was about 28. and those are deaths specifically attributed to fatigue-related driving, not all crashes and deaths related to

truck crashes. >> so the -- what you're saying you go from 500 to what number next year? >> well, again, you're presuming next year the rule is in effect? we are still in a proposed rulemaking stage -- >> well, whatever year is a good year. >> you know, let's flash forward when the rule is fully in play and this is a proposed rule. under the option where we propose 10 hours of driving time which was the agency's preferred option, we would see a reduction, an estimated reduction in deaths of approximately 49. >> okay. >> and under the 11-hour option of 26. >> and what was the other number -- what's your projection suggest on the 3300 fatality number, overall number? >> i don't have that. i don't have that but we'll certainly follow up if we can project that. >> okay. well, i want to thank you for coming today. we had, i think, a good discussion with our first panel. and because we have no other members here and i apologize it's the nature, as you know,

congress' schedule, that we didn't have more of our members able to ask you questions but thank you for coming. >> well, if i might just in closing real quickly re-enforce the purpose of this rule is to reduce fatigue-related crashes involving truck by reducing and setting improved rest breaks and improved likelihood of rest for commercial professional commercial drivers. it is our obligation as a federal agency to strive towards the safest operating environment as possible for commercial vehicles and protect the public. and we feel strongly that the proposed rule heads us in that direction. >> thank you. >> thanks, mr. chairman. >> you bet. thank you. >> and we're adjourned. [inaudible conversations]

[inaudible conversations] [inaudible conversations]

>> next a senate panel examines the use of antipsychotic >> it's on convenient to listen

to c-span anytime anywhere with the free c-span radio app. you get streaming audio of c-span radio as well as all three c-span television networks 24/7. you can also listen to our radio programs, q & a, the communicators and "after words." c-span, it's available wherever you are. find out more at c-span.org/radioapp. >> next a look at the use of antiantipsychotic drugs on dementia patients and long-term care facilities. testifying before lawmakers were official officials including the health and human services inspector general. and advocates for the elderly who talked about possible life-threatening or other adverse effects of this drugs on patients. this hearing of the senate special aging committee runs about an hour and 40 minutes. >> good afternoon. to all of you we appreciate you being here today and we'll

commence the hearing at this point. today we will be discussing the widespread and costly and often inappropriate use of antiantipsychotics in nursing homes and efforts to find safe and effective alternatives. well, antipsychotics has been approved by the fda to treat an array of psychiatric conditions, numerous studies have concluded that these medications can be harmful when used by frail elders with dementia who do not have a diagnosis of serious mental illness. in fact, the fda issued two black box warnings citing increased risk of death when these drugs are used to treat elderly patients with dementia despite these warnings there's been little impact on antipsychotic rates in long-term care facilities for dementia patients who do not have a diagnosis of psychosis and

there's an increase of antipsychotics in nursing homes with people with de men tia and more than half of these patients have been prescribed these drugs. improper not only put the nation's health at risk it also leads to higher health costs. today we'll hear testimony by the h. -- hhs inspector general that the use of antipsychotics in nursing homes on patients without a diagnosis of mental illness is costing taxpayers hundreds of millions of dollars every year. now, we know that we can do better. our second panel features experts including tom hlavacek from my own state of wisconsin who will be discussing safe alternatives in using antipsychotics in older patients and antipsychotics can offer beneficial treatment for

individuals suffering from mental illness. however, we have a responsibility to patients and to their families to ensure that elderly nursing home residents are free from all types of unnecessary drugs. and we have a responsibility to taxpayers to be sure that they're not having to pay for drugs that are not needed. toward that end, i'll continue working with my committee colleagues as well as senator grassley to address these issues. so we do thank you for being here and we will turn to our first panel. our first witness will be daniel levinson, inspector general of the health and human services. we thank you for being here. our next witness on the panel will be dr. patrick conway, chief medical officer for the centers of medicare and medicaid services and director of the office of clinical standards and quality.

we thank you for being here. mr. levinson? >> good afternoon, chairman. thank you for the opportunity to testify about the use of a typical antipsychotic drugs in nursing homes. these drugs are powerful. and misuse poses a risk to the elderly. two recent oig reports raised concerns about the use of antipsychotics by elderly nursing home residents particularly those with dementia we hired psychiatrists expert in treating elderly patients with a sample of medical records their review revealed the following. in 2007, 14% of nursing home residents or nearly 305,000 patients had medicare claims for antipsychotic drugs. half of these drug claims should not have been paid for by medicare because the drugs were not used for medically accepted indications. for 1 in 5 drug claims, nursing

homes dispensed these drugs in a way that violated the government standards for their use. for example, the prescribed dose was too high. or residents were on the medication for too long. finally, prescription drug plans sponsors lack access to information necessary to ensure appropriate reimbursement of part d drugs including antipsychotics. what do these findings mean? too many institutions fail to comply with regulations designed to prevent overmedication. and medicare pays for drugs that it shouldn't. why should we be concerned? these powerful and at times dangerous drugs are too often prescribed for uses that are not approved by the fda. and do not qualify as medically accepted for medicare coverage. the fda has imposed a black box warning emphasizing an increased risk of death when used by

elderly patients with dementia yet, 88% of the time, antipsychotics were prescribed to elderly patients with dementia physicians can use their medical judgment to prescribed drugs for uses not approved by the fda including to patients for whom the boxed warning applies. and most physicians and nursing homes dispense antipsychotic drugs with the best interest of patients in mind. however, it is concerning that so many elderly nursing home residents with dementia are prescribed antipsychotics. for instance, without a medical workup one patient was given antipsychotics for agitation. a medical exam would have detected this patient's urinary track infection which may have been a sense of the agitation. how can we help protect this vulnerable population? cms should consider enhancing claims data to ensure accurate

claims determination. for example, adding diagnosis codes to drug claims could help determine whether prescribing is appropriate and that the claim is payable. two, hold nursing homes accountable for unnecessary drug use through the survey and certification process. and three, explore other options such an incentive programs and provider education to promote compliance with quality and safety standards. for example, cms could require nursing homes to reimburse the part d program when claimed drugs violate. the government must monitor the marketing antipsychotic. there's ample evidence that some drug companies have illegally promoted these drugs for use by the elderly with dementia drug manufacturers have paid billions of dollars to settle allegations of off-label marketing of these drugs. it is difficult to undo the influence of such marketing

campaigns. doctors, nursing homes and pharmacies can all help by carefully analyzing the best patient when analyzing and dispensing antipsychotics. in partnership with medical professionals, families can support their loved ones by learning about appropriate use, proper dosages and possible side effects. my office continues to examine protections and quality of care for patients receiving antipsychotics. we are reviewing whether nursing homes are completing required patient assessment and care plans for these residents. and we have issued guidance to nursing homes about compliance risk related to the use of antipsychotics and other psychotropic drugs. over the next 18 years, 10,000 americans will become newly eligible for medicare each and every day. as the baby boomer population ages, it is imperative to address the overuse and misuse

of antipsychotic drugs for nursing home patients. thank you for this issue and i'm happy to take your questions. thank you. >> thank you very much. dr. conway. >> thank you so much for to ensure that antipsychotics are using appropriately. cms is ensuring that every medicare and medicaid beneficiary si receives appropriate and high quality health care. i took on my public servant role six months ago in order to improve the role to all americans. it's a significant opportunity for improvement and our nation's services deserve our collective focus and i thank the committee for he bringing the attention to issue. cms is engaging with external stakeholders to eliminate inappropriate use of antipsychotics in nursing homes. i will briefly summarize multiple steps that we have already taken in our plans for the future. i will highlight seven components to our approach. survey and certification,

training and education, updating rules that govern nursing homes, research, quality measure development and transparency, partnering with states and collaborative quality improvement. first, to help ensure that nursing homes meet both federal and state standards cms conducts all facilities participating in medicare or medicaid. cms has implemented substantial improvements to help address concerns of overutilization of medication. cms revised guidelines for unnecessary medications including requiring providers to use nonfarm logic interventions such as time exercising, time outdoors, managing pain or planned individualized activities. cms is working to enhance the implementation of the fines and utilize our quality assessment and improvement program better. the swearers are our armies of quality assurance in the field and we will focus on appropriate behavioral intersection. cms is working on training to provide patient-centered care that emphasizing nonfarm logic

interventions when appropriate. cms added language to the state operations a make it part of mandatory training. cms is producing an educational dvds that emphasize interventions and that will be distributed nationally to all nursing homes and state agencies. finally cms updated the training and curriculum to improve swear skill at detecting unnecessary medication use. third, cms is updating its rules regarding nursing homes and antiantipsychotic use. and there will be farm cysts to be pharmacies so -- cms is opening and consider updates to other rules governing nursing homes. fourth, cms is conducting research and leveraging research findings into practice, for example, cms has awarded a contract to conduct a study in 20 to 25 nursing homes that will evaluate nursing home decision maker and factors influencing

prescribing practices for antipsychotic medications. fifth, cms is seeking to encourage the quality measure of addressing antipsychotic use and once validated cms will publicly post the outcomes and cms will identify and spread best practices, for example, cms funded work with illinois to use enhanced nursing home drug data to inspect and monitor issues related to antipsychotic use. finally and perhaps most importantly we have recently engaged in a multistakeholder quality improvement initiative focused on reducing antipsychotic nursing homes by eliminating inappropriate use. i have personally led and participated in national quality improvement initiatives and have seen their power to transform health care. these efforts are most successful when they engage a broad range of stakeholders of clinicians, patients and families. therefore, a few months ago we began proactively reaching out to stakeholders into the american director association and consultant pharmacist, it is

american health care association, leading age consumer voice, professional societies, government partners and others to participate in a national collaboration. the response has been positive and we are in the process of developing a national action plan. we are no, i did accomplish our shared goal. i want to briefly share three of our guiding principles from the cms office of clinical standards and quality that i led our organization in drafting. first, constant focus on what is best for the patient. second, being a catalyst for health system transformation and improvement. third, collaboration across hhs and with their external stakeholders and partners. this is our approach going forward both to dramatically improve the care of patients with dementia as well as other issues we tackle. cms seeks to function as a major force in trust worthy partner for the continue improvement of health and health care of all physicians. i personally take this commitment very seriously. for nursing home residents suffering from dementia, this involves comprehensive behavioral health by an interdisciplinary team who are

knowledgeable in the use of nonfarm logic interventions and appropriate judicious of medications when indicated. we hope the members of committee will serve as important partners in these efforts and i look forward to hearing your comments and answering your questions. i have to mention that my wife just gave birth to our third child, so if i seem sleep deprived of my answering of questions, i apologize. thank you for your time. [laughter] >> thank you very much, dr. conway for being here. mr. levinson, your study found that half of the 1.4 million atypical antipsychotic drug claims for nursing home residents did not comply with medicaid reimbursement criteria 'cause they were not used for medically accepted indications. how can we increase medicare's access to the information it needs to ensure appropriate reimbursement for drugs? >> well, our report included

several recommendations and in my summary statement i was including some of the options that i think cms needs to explore but first and foremost, you know, if we could have diagnosis information as part of the prescription, that would go a long way. it wouldn't necessarily solve the entire problem but having the diagnosis information available on the prescription could make potentially a significant difference in being able to ensure that the sponsors actually understand that indeed this is for a medically indicated application. >> now, in almost every case, the prescription comes from a physician. >> uh-huh. >> correct? >> yes. >> well, the physician understands how he is to prescribe for dementia and how he's to prescribe for mental illness how is this mistake being made -- after all, it's

not just anybody that decides what to administer to a patient. it's a physician. so how does this happen? >> well, we are focusing on is cms' need to require the pdp sponsors to ensure that they have the diagnosis information available because if you're reimbursing only half the time accurately, that is a problem that cries out for the need to ensure that cms is saying, we need to ensure that we are only paying for those prescriptions in which we can support either fda or off-label but medically indicated application. >> and i appreciate that. but i'm trying to -- something i'm trying to understand the medical part of this because it's dangerous to prescribe inappropriately, right? i mean, we're talking about patients who are at risk from inappropriate prescription?

>> well, you know, on the medical expertise i would defer the doctor to the table but i would indicate that doctors are free to prescribe for any occasion. >> sure. dr. conway, do you want to help us understand that? >> we agree with the point that we have a shared goal for appropriate prescribing. our view of this, as i outlined, is a multifaceted approach to appropriate prescribing and we think about it in the course of all of our levers. so on one hand, education and training so i agree with you the decision should be between a physician and the patient. but there probably is additional education and training for nursing home staff and physicians on this issue, especially, around nonpharmalogical interventions. second, in terms of measurement and data, we agree with the oig on the importance of data and on measurement as i alluded to we're looking for additional measures so we can track this

information. i won't count on everything that i went through. if there's outlier nursing homes with potential issues, you know, we are working through a process to make sure we have appropriate quality assurance in those settings for those nursing homes. >> you regard this is a solvable problem, perhaps not easily but a solvable problem? >> i do. >> let me put it another way. is there any reason other than our inattention for patients to be prescribed improperly? >> so i do believe that it's a solvable problem. i think it's a complex problem exactly as you said, senator. i think addressing complex problems such as this especially where the symptoms are sometimes difficult to distinguish as opposed to some other disease processes where it's more

obvious and i can talk more about that if you want me to. i think here it's a solvable problem but it will be qualitative problem and a key is this focus on nonpharmalogical treatments. we educate nursing homes and patients and families about the nonpharmalogical treatments to treat with dementia and patients with dementia >> do you agree with that, mr. levinson? >> yeah, i think that can be extremely extremely helpful. that's very important. what is truly appropriate is a matter for the doctor to decide, perhaps in consultation with other medical professionals. the concern from the inspector general's standpoint is that cms is reimbursing half the time where we just can't establish that there are actual -- the actual medical indications that

the cms manual requires for there to be appropriate reimbursement. >> okay. senator manchin? >> thank you, mr. chairman. dr. conway, if you've gone over this, i missed it before i got here, i'm sorry. the inspector general's report found over half of antipsychotic claims, about 723,000 out of a million four, for the residents did not comply with the medicare reimbursement criteria, which is, i think, what mr. levinson is speaking about. and -- i mean, i mean, that's an alarming -- an alarming rate. what authority do you need to create incentives to promote within the rates of noncompliance you have now? >> i agree that cms should not be paying for medically

inappropriate uses of medications. i think it is an inappropriate payment issue and it's also a quality of care issue as i did allude to on the survey and certification and that we're measuring quality in just area and historically we're not. we'll be able to do that this spring and transportly sharing that information with beneficiaries on benefits with nursing home care. i think in addition, with our part d colleagues, you know, we continue to work with pdp drug plan sponsors. we actually recently asked for more that we could do in this area in terms of input there so i think it's a multifaceted issue. we agree with you that we should not be paying inappropriately. i think our current authorities achieve that goal. we would survey and certification now reports to me. i would reiterate, you know, the president put in an fy'12 budget. it would allow us to do the important work on survey and

certification on nursing homes but i think we have the appropriate statutory authorities currently. and as i outlined we're going to take a multifaceted approach to address this issue. >> a lot of states have basically their own controls, their oversites, ombudsmans things of this sort. are you exchanging information freely? i looked -- just the figures of 2007, $309 million was spent. well, if that was half of it spent or misspent that's 150 million. that was in $207. i could only guess what it is now. how do you all interact with the states? >> so we work closely with states now and we think we need to do more in the future so we're partnering with states, illinois, we're identifying what may be inappropriate uses of antipsychotics. massachusetts is convening a multistate holder group to

address this group. so we are closely working with states including the state-based survey agencies in terms of addressing this issue. >> the states are doing -- aren't states doing more visitations to nursing homes than what you would say you are able to do? >> yes. so it is -- the state survey agencies will survey -- >> are they trained? have they been trained properly to look for the types of so-called overprescriptions or abuse that might go on? >> it's a great point. so one of the aspects that we are trying to address is better training so we've started that through a series of -- as an example, educational dvds on this issue. direct training with surveyors and reaching surveyors and people in the nursing homes about nonpharmalogical treatments and that's appropriate as you outlined to both the providers of carries and the surveyors are understanding the appropriate of the treatment and using the use

of antipsychotics and the nonpharmalogical interventions that are possible to treat these problems. >> here i was reading -- it said these treatments are administered despite fda box warning concerning increased risk to mortality when drugs are used for the treatment of behavioral disorders in elderly patients with dementia and no diagnosis of psychosis. >> it's out of sight out of mind keep them calm? >> that's not our goal. >> that looks like what the results have been? >> on the fda label, so as you know, many medications are prescribed off-label. however, we would always want appropriate use of antipsychotics to give some tangible examples. if a patient with dementia has delusions or hallucinations or serious mental disturbances that can be appropriate use but we would like to have the nonleft arm logic treatments being used more often. >> let me say it's really a

shame in this great country as we spend in nursing home care and not to get a better quality of care for people. it's really nonexcusable. >> i agree it's a shame and i agree we need to do better. >> thank you. >> senator grassley? >> thank you. i appreciate the opportunity and the information to come and participate in this hearing. thank you. i have just one question for each of you. i'll start with general levinson. in your testimony, you highlighted the extensive evidence that drug companies have illegally marketed their atypical antipsychotic for off-label use. you mentioned one company that used the slogan 5 at 5 to promote their powerful antipsychotic as a sleep aid for patients. eli lilly sales representatives told the doctors that giving 5 milligrams of their drug diprexa at 5:00 pm would help their patients sleep. in 2009 this country pled guilty

to illegal promotion and paid money to settle a federal lawsuit compared to the revenue this politic buster drug generated, that large number becomes less significant and, unfortunately, just the cost of doing business. now, as you described, it is a profitable investment because even after government action stops illegal marketing, their effect on prescribing patterns may be difficult to undo. so my two-part question, general levinson, is there a system currently in place to educate prescribers to discuss this misleading of drugs. >> providing training is absolutely essential senator agreesly and whatever is in place now needs to be far more robust. that is a key take-away i would hope from what has been examined and what has been reported on is

that there needs to be far greater understanding of the potency of these drugs and their appropriate application and how you're going to use the back door as opposed to the front door of advancing this kind of drug regiment, it really needs to come with a really good understanding of what people are doing. and it's hard to believe that in the past, that really has been effective just given the record of litigation. since we've had not just that case but nearly half a dozen major settlements with drug companies over the past several years totaling billions of dollars that were one way or the other involved these antipsychotic drugs. so it's a very important key. part of the puzzle, if you will, that needs to be really made far -- it really needs to be strengthened. and we're doing our part trying to advance the provider training initiatives. and we're going to continue on quality of care to do much the

same by drilling down an understanding, individual plans of care to see exactly how nursing homes are actually trying to implement a far more effective plan for patient safety. >> okay. if there is -- if there is such a system, it's inadequate, you just said, and it needs to be improved or maybe even replaced. do you have some idea of how that system should be? and is it possible if it needs more money using a portion of the settlements of off-labeled marketing? >> well, we would certainly stand very ready as we always have to provide the kind of technical assistance that we do day in and day out to cms which really has the program responsibility to design these kinds of efforts. we don't run the program. we evaluate it.

in terms of a kind of counter design, my chief concern would be how we would oversee how the government would actively seek to provide some kind of counter-balance to it. wearing the oversight hat, that presents some challenging issues about how you, i take it, level the playing field, make sure people understand pros and cons comprehensively. so -- i mean, that was a significant oversight challenge. and, therefore, it would be important to get it is details of that kind of design right and we would stand ready to certainly help. >> dr. conway, you mentioned proposed changes cms is considering to require long-term care pharmacists to be independent from other pharmaceutical pharmacists. there's, obviously, a clear potential for conflict of interest.

however, one large long-term care pharmacy reported to me and i won't give the name of that group that all of the antipsychotic recommendations made by their consultant pharmacists -- 99 and 7/10 percent of those reductions were to reduce or discontinue the antipsychotic dosage. one problem they presented was that these recommendations are often rejected by prescribing doctors who believe that high dosage is appropriate. does cms keep data on recommendations made by consultant pharmacists and whether or not they're implemented? let me ask it the same time. does cms require justification from a prescribed physician when they choose not to follow a recommendation? so two questions. >> yes, sir. on the first question, we are not currently capturing data on

recommendations from the long-term care pharmacist to physicians 'cause that's within the nursing home care setting. i think as i alluded to earlier, i think the education component is not just in the pharmacy world. it's to also physicians. i'd also say it's to patients and their families, caregivers, nurses, cna, so the whole nursing home community, if you will, which we think it will make it a much more receptive audience to recommendations. on the long-term care pharmacy issue, you know, it is a proposed change and as you alluded the proposal was to -- an attempt to ensure that financial arrangements weren't influencing the recommendations from the long-term care pharmacy. >> what about the -- i hope you didn't answer this. if you did, i didn't it get. does cms require justification from the prescribing physician when they choose not to follow recommendations? >> i apologize, sir, i didn't answer the second part. we currently do not require a

written justification per se. it is similar to other prescribed medicine. the physician and the patient should have a discussion about the medication, the risks and benefits or the patient's family in this case and then the prescription -- either the increase or decrease in dose or stopping a prescription would take place. but like other prescribed medicines, there's not a justification -- a written justification captured for the prescription. >> thank you very much, mr. chairman. and thank you, witnesses. >> sure. >> thank you very much, senator grassley. senator bloomen thal. >> thank you, mr. chairman. first of all, my thanks to our chairman, senator kohl, for having this very important hearing and for senator grassley's continuing investigation into this issue which has been very, very important. overusage of antipsychotics as i don't need to tell the two

witnesses and probably most of the people who are attending today is a form of elder abuse, plain and simple. it's a form of abuse of people who often have no idea what is happening and maybe their families may not have a clear or informed idea about how these drugs are prescribed and applied. but it's a routine pattern and practice as some of the statistics show i don't know how many of them have been cited here but 83% of claims for use of these antipsychotics to medicare were associated with off-label conditions like dementia 51% of medicare claims for these drugs were erroneous of dollars were wasted. so the question is, at the outset, if there is off-label

marketing, which is plainly a violation of current law, as opposed to off-label prescription, which may not be, can you give me specific instances -- both of you cite it in your testimony of off-label marketing occurring what companies? what drugs? >> we've had a number of cases. of the 18 settlements that we've had senator blumenthal, i believe 5 in the past two years have involved antipsychotic drugs. >> i'm thinking more of going forward of what's occurring right now? >> well, i can give you past cases but in terms of current investigations, i certainly wouldn't be in a position. it would be -- it simply wouldn't be proper to be talking

about whatever current investigations might be ongoing with us as investigators in the justice department and as prosecutors. but we have certainly a record of the kinds of cases you describe that i think are a very important body of work that really underlay our evaluation work that we undertook to see further exactly how extensive the problem is in nursing homes with the percentages. and then to build on that work by looking at patient plans of care. the litigation work that we have been involved with in partnership with the justice department laid the foundation for the report that's now before you, at least in part. and that's the report that's now before you will add further information and understanding to what is actually going on, if you will, on the ground and will lead to a further investigation of plans of care in nursing homes to see how the mechanics of this actually is either operating or not operating

appropriately. >> are the penalties for off-label marketing in your view sufficient to detour it in this area? >> well, i mean, based on the record it looks as if we're still facing a significant health issue. >> exactly right. >> there's no question about that. >> so your answer is probably no. but that might be for others, you know, to answer. >> well, you're in charge of enforcement. >> well, under enforcement -- we have quite an enforcement record that we've built. >> which is why i'm asking you the question if anyone is expert on the issue of deterrence, it is you. and that's why i'm asking you the question. >> well, we certainly view these kinds of returns and we're talking about billions of dollars as a considerable amount of money. what happens with respect to the kind of cost benefit evaluations that are undertaken by others.

it certainly is very, very troubling that we have not just a case but we do have a string of cases. and, therefore, you know, there's plainly a need to do more. >> in this area, would you suggest that there ought to be specific prohibitions applicable to the providers in addition to the companies for off-label use in the area of use of antipsychotics or nursing home treatment. >> i think in antikickback statutes and we've had cases where we've actually pursued at the provider level, i do think everybody needs to take ownership of the problem throughout the health care system. and it's not just a matter of the folks who are actually producing the drugs, i would agree with that. >> so perhaps in the area of

nursing care, the penalties for off-label marketing should be also applicable to providers or are there some institutional responsibility for off-label use? >> well, on the institutional responsibility, the -- one of the chief concerns we have as reflected in this report is that more than 20% of the time -- even when the drugs were used for medically accepted indications they were being used for too long or improper doses. there's a lot of misapplication that's actually going on within the nursing home setting itself. ..

>> was behind this all? >> well, chairman kohl, i think that's all we need to further examine. and that's why i emphasize the follow-up and reporting we're going to be doing, and i certainly will defer to doctor conway to get his kind of medical perspective on it. but we don't begin this kind of evaluation with any go of what

is the right number of dosages or how may prescriptions should be allocated to this particular part of either the drug world over these kinds of issues. we look at what cms requires in terms of what is reimbursable and what isn't, and that kind of gives us our roadmap. it concerns a concert will% of elderly nursing home residents with a great deal of money involved. and as we've talked the last few minutes about the enormous investment of hours from the pharmaceutical industry, there's a lot at stake here. and given how much is at stake here both in terms of patient safety and financial investment, i think all of us as public officials need to do our part to make sure that there's a much better transparent and accountable understanding of exactly how these very powerful, important and very positive

drugs in the right setting need to be used in the to be paid f for. >> are you of the opinion that into you to come it's going to be significant improvement? >> i'm very careful in the inspector general's role not to reject so much us to evaluate what has happened in certain try to advance recommendations that will provide positive outcomes in the future. but in terms of what people will do either in response to this report, we hope they will take actions that will indeed fulfill that kind of positive prediction. >> what about you, dr. conway, do you think will make significant improvement in the next year? >> i do think we're the right components in place to make significant improvements. so specifically, i think engaging the multi-collaborative approach as i outlined whether it is leading age, so that other

folks in the room where i think we've met a very receptive audience but i think behavioral change is complex and we're asking for behavior change away from medication based regimen in many cases where non-pharmacologic treatment regimen. i think as i outlined if we aligned the levers of survey and certification, quality measurement and reporting, education and training, and a true quality improvement collaborative focus on this goal which i think we have drafts of a national action plan, you know, working with these external stakeholders, i think we have the potential for significant improvement. >> thank you, mr. chairman. and if i could just ask the question, this didn't happen overnight. you've seen the telltale signs for quite some time, the increased amount of reimbursement, and it's grown in pretty rapid succession. didn't it raise anyone's a long,

did anyone's alarm go off that something could be wrong? >> i'll start to try to answer that question. so, -- >> i'm just saying, if, when i look back at the years and increase in reimbursement that means increased usage. are there other things like this that would be a telltale sign that there are abuses going on the basically having come to the forefront that you all can see the change in reimbursement that should have told us that something needed to be done much sooner than this? >> then i'll start and then, so, i think certainly this is an issue, and in interest of full disclosure i've been in this role for six months i can't speak to the history as specifically prior to that. but i think this is an issue that there was awareness of. i think the awareness has grown. i think at cms we have done some

things already on this issue in terms of guidance, survey, certification and center. i think with much more to do so i think, and then on the sort of coverage and reimbursement issues i would largely defer to my medicare reimbursement colleagues on the coverage of reimbursement issues. >> and the kind of reporting that we did does take time. i mean, we are looking at, in our report we looked at the first half of 2007 and we asked medical experts to actually do the medical record review here and, therefore, we are looking at information that is now, exists several years old. but we do, and we've been involved in the cases that involved that, that resulted in significant settlements with pharmaceutical industries on these kind of drugs. for the last few years. so we know that this is, this has been a very large issue for us on that litigation front, as

part of the settlements there have been corporate integrity agreements that these companies have had to signing with very robust compliance requirements that we in turn are in the process of monitoring. >> to you all have any litigation going on right now with any companies that you know of or that you probably suspect any type of fraud whatsoever? >> well, chances are my counsel and might office of investigations would advise me not to talk in public about ongoing investigations. and i try to adhere to their guidance. >> that's a good policy to accept, to follow. the only thing that bothers me more than anything is how much fraud and abuse and waste goes on in the health system. in anybody's budget, if we see a spike in reimbursement, request reimbursements, that should alarm that something is wrong. the easiest way out is the most profitable way, or you're sleeping -- sweeping under the rug. i don't why some has evaluated

this, whether you're medical staff are whatever. where does the flag go off or -- i keep asking the same question, i know, but then maybe you need to change, change fields overview or oversight. >> i do think that there is considerable promise in the initiative of accountable care organizations of coordinated or integrated care to get health care professionals in different corners of the health care industry doing business with each other any more integrated way that has existed in the past. that does have promise to an effect serve as a very useful way of people being able to understand what kinds of therapies, whether its pharmacological or otherwise, make the most sense for the patient after all, we are dealing with a system in which the great majority of the health care providers are honest.

they are professional. they are trustworthy. they are people who we really count on to take care of us and our families. and the great majority of time, they do so. so what we need to have is a system that really brings out those strengths and keeps the weaknesses, the marginal players, out of the system entirely or at least at bay so that we don't have an issue that is as serious as this on both safety and financial grounds. and i think that's a very good, positive development that i know cms and other parts of hhs are not in that midst of unrolling this coming year, the future. i'm hopeful it will have benefits on the health care and abuse front as well. >> we thank you both for being here today. you've added a lot to the discussion of this important issue. thank you so much.

we will now turn to our second panel. on the second panel we will have for distinguished witnesses. first will be hearing from doctor jonathan evans is the incoming president and the american medical directors association. next we'll be hearing from tom hlavacek. mr. hlavacek gartley serves as executive director of the alzheimer's association of southeast wisconsin. our third witness will be toby edelman, senior policy attorney for the center for medicare advocacy. and then we'll be hearing from dr. cheryl phillips is a senior vice president of advocacy of

leading h. we thank you all for being here. now, dr. evans, you may commen commence. [inaudible] although my testimony today is quite personal, i also represent the professional society for long-term care physicians whose mission is to improve the quality of care for seniors. my personal story is this, i'm a doctor specializes in the care of frail elders. i practiced mostly in nursing homes and other long-term care settings where physicians are frequently absent. i do use antipsychotic drugs to treat a small number of patients with long-standing schizophrenia or bipolar disorder. i do not prescribe antipsychotic drugs for treatment of agitation or other behaviors in patients with dementia. the entire leadership of knowledge is the use of these medicines with patients and things only as a last resort and

only when all else has been tried and failed, which is rare. i and other like-minded doctors face tremendous pressure in all care settings to prescribe medication to make infuse patients behave. most of the time of this equates to chemically restraining the patient. this pressure comes from frustrated caregivers and family members who have been led by other health care professionals to believe that these drugs are essential. a large number of patients that i see were started on and that's a cut of drugs and hospital for reasons that are entirely unknown. i routinely stop these and many other unnecessary or inappropriate drugs in patients admitted to my care. nevertheless, my efforts to avoid or eliminate at a psychotic drugs often put me at odds with facility staff, patients and families come and other health care professionals. the rate of off-label and a psychotic drug use there is greatly facilities and prescribers, and based upon the culture and attitude and not based upon medical diagnoses of

illness or symptoms. federal regulations regarding at a psychotic drugs unnecessary medications and chemical restraints only apply to nursing homes but the prom of overprescribing at a psychotic drugs exist in all care settings. the majority of off-label anesthetic drug prescribing occurs outside of nursing homes. it is a firm fixed belief among many health care professionals that undesirable behavior is cause for medication and that medication will be very likely to work. that firm fixed belief is false. but it's based in part on inadequate training to understand behavior and care for can see used -- and toothpaste. most doctors treated as a disease that requires medication. these drugs are used as chemical restraints. the real concern should be for improved dementia care in all settings that folks understand behavior and its meeting in order to meet the patient's needs. most of the time using drugs to stop behavior isn't doing the right thing. using drugs is instead of the right thing.

using drugs to try to make people behave creates unrealistic expectations and distracts caregivers from solving the underlying problems resulting in these behaviors. behavior is not a disease. behavior is communication. people have lost the ability to make it with words, the only way to communicate is through behavior. good care demands within that what they are telling us and help them. undesirable behavior in dementia is usually reactive and occurs in response to a perceived threat or other misunderstanding in patients who by the very definition of the disease have lost some ability to understand. these behaviors ribs in a conflict between a patient and their environment. us. often we have to change our behavior in order to prevent and undesirable but entirely predictable response. amda believes an approach and is working with others to change the culture of health care in the united states. a minimum requirement of

patient-centered care is informed consent. patients and families must be afforded sufficient information and dialogue to make appropriate treatment decisions regarding potentially harmful medications. likewise, we respect and strongly agree with existing federal regulations regarding the avoidance of chemical restraints and unnecessary drugs. we are developing core for physicians and long-term care. we're raising the bar for dementia care, and helping dedicate an caring individuals to leap over that part. we are educated and empowering physician medical directors and attending physicians and long-term care, and we believe these efforts will lead to the kind of health care quality that we all want without increasing cost. there's a substitute for good doctors spending time with their patients and families, the time you need to solve problems and really some good doctors are more often present and engaged interest in facility care use fewer health care resources and fewer antipsychotic drugs. physician training does work to reduce antipsychotic drugs and

amda provides training and is working to provide more. we acknowledge that virtually every dollar of health care spending at some point occurred as a result of a doctor's order. being a good physician requires being a good steward of scarce resources and focusing on what works. what the money is spent on should be a reflection of what we value most as a society. what my college and i value most is loving care. thank you, mr. chairman, there's a of the committee. >> thank you very much, dr. evans. mr. hlavacek. >> good afternoon, chairman kohl, and senator manchin. thank you for the opportunity to discuss the faces problems that overutilization of atypical antipsychotics present for people with alzheimer's disease. particularly those who reside in long-term care. unfortunately, the alzheimer's commuting in wisconsin has seen firsthand what can happen when an individual with dementia is prescribed antipsychotics without proper precautions. at the time of his death,

richard peterson, a friend of center goals, was an 80 year-old gentleman with a late stage dementia who exhibited challenging behaviors and in long-term care facility. after being at two hospitals in an effort to have his behavior treated with antipsychotics, he was placed under emergency detention and was transferred by police in a squad car in handcuffs to the milwaukee county behavioral health and psychiatric crisis unit. his family found him bear tied in a wheelchair with no jacket or shoes. in spite of his family's efforts to intervene and seek better care, he very quickly develop pneumonia, was transferred to a hospital and died. richard peterson worked hard all his life, raised his family and contributed to his community in many ways. he did not deserve to die in the way that he did. mr. peterson's death was not an isolated incident. it was the latest in a string of incidents in southeastern wisconsin that involve tragic outcomes related to alzheimer's

behaviors and antipsychotic medications. in response to the growing problem, the alzheimer's association of southeast wisconsin and other concerned stakeholders created the alzheimer's challenging behaviors task force. our local task force included 115 members from all perspectives on the issue, and published handcuffs, report that provides a basic understanding of issues surrounding behaviors and approaches to addressing the problem. in wisconsin, we found a reliance on atypical antipsychotics that were sometimes very poorly prescribed and administered. we found examples of untreated medical conditions such as urinary tract infections, tooth decay, and arthritic pain, that let you agitated behaviors. and, of course, atypical antipsychotics will do nothing to treat those underlying medical condition. were also found negative outcomes from the relocation of individuals in and out of hospitals in long-term care

facilities. our experience indicates that these characterizations can exacerbate behaviors, and often lead to escalating drug treatments. the task force one local example of how the alzheimer's association advocate for quality care and long-term care settings across the country come including the reduction of inappropriate use of antipsychotics. recently, the national alzheimer's association board of directors approved a position statement titled challenging behaviors which discusses the treatment of behavioral and psychotic symptoms of dementia, otherwise known as bp s. d. i have included "handcuffed" and the board statement with my written testimonies. the alzheimer's association strongly believe one mechanism for reducing care transition and improving overall care for residents in long-term care is to raise the level of expertise

of facility staff through training and education. the alzheimer's association has developed to dementia care training programs, specifically for staff, the classroom-based foundation of dementia care, and the online cares program. both of these training programs have been identified by cms as option for nursing facilities to satisfy the requirements of section 6121 of the affordable care act, which calls for dementia care training for certified nurse aid, working in nursing homes. the cares program has a new module, dementia related behavior, that focuses on nonfarm is a logical strategies for reducing or eliminating challenging behaviors. local alzheimer's association chapters across the country are excellent resources for these and other training programs to enhance care and support for persons with dementia and caregivers. the alzheimer's association also developed dementia care practice recommendations for assisted living residences and nursing homes.

these are the basis our campaign for quality residential care. these standards of care will improve quality of life for people with dementia. the also is association is committed to ushering people with dementia have access to high quality care and strongly believes that non-pharmacological approaches should be tried as the first line alternative for the treatment of behaviors. senator kohl, and mr. mentioned them think for the opportunity to address this issue, and we look forward to the opportunity to work with the committee in the future. >> thank you very much, mr. hlavacek. >> thank you, cynical and senator manchin. congressional attention to the misuse of and the psychotics is long-standing. in 1975, this committee issued a report, drugs in nursing homes, issues high cost, and kickbacks.

in, 20 years ago this committee held a workshop on reducing the use of chemical restraint in nursing homes, that identified many of the same issues we're discussing today. the misuse of drugs and the need for staff to see residents behaviors as communication, not problems. the inspector general's very important may report actually understate the extent of the problem because it focused only on atypical antipsychotics, not conventional antipsychotics as well. nursing facilities self-reported data indicates that in the third quarter of 2010, 26.2% of residents had received antipsychotic drugs in the previous seven days. that's approximately 350,000 individuals. facilities reported to cms that they give antipsychotic drugs to many residents who did not have a psychosis including almost 40% of residents at high risk because of behavior issues. i want to make several brief points this afternoon. first, federal law prohibits the

anti-psychotic drug practices we see in many facilities. second, why our antipsychotics are so misuse. third, the high financial cost of these drugs them and finally some solutions. the federal nursing home reform law since 1990 -- since 1990 has limited the use of pharmacological drugs. implementing regulations and cms guidance to surveys are very strong that they are inadequately and ineffectively enforced. second, while there are many reasons why these drugs are inappropriately prescribed, the most significant cause is the serious understaffing in nursing facilities. most facilities don't have enough staff and enough staff with specialized and professional training to meet the residents needs. in addition, the enormous turn over in staff and a lack of consistent assignment of staff to residents means that staff don't know the residents they are caring for. they are less able to recognize and understand residents nonverbal communications or changes in condition that could

warrant an appropriate care intervention. a second key reason for misuse of these drugs is the aggressive off-label marketing psychotic trucks which were talked about today. to give one example, in 2009, the eli lilly company paid $1.5 billion to settle civil and criminal charges for the off label promotion as a treatment for dementia. eli lilly trend is long-term care sales force to promote the drug as a treatment for dementia, depression, anxiety and sleep problems. a third concern is that many consultant pharmacists who are critical to implementing the federal provisions, have not been independent. another false claims act case against johnson & johnson charged that facility with paying kickbacks to omnicare, the largest nursing here pharmacy so that the pharmacist would recommend it to drugs, including for use by residents. the consultant pharmacist was

part of the salesforce. there are other reasons as well, of course but drugs have replace physical restraints as used in an antipsychotic drugs are protected class under medicare part d, and they're generally not subject to utilization control mechanisms. i'd like to discuss briefly the high cost of antipsychotic drugs. they are very expensive pick the top selling drugs in the united states generating annual revenues of 14 points $6 billion. but the cost of cores extend far beyond the cost of the drugs themselves. residents or inappropriate given these drugs experience a number of bad outcomes that are expensive to try to correct. falls, hip fractures, income and income each with a high price tag can be the result of the misuse of antipsychotic drugs. millions and billions of dollars of these poor outcomes cost were identified in the 20 year-old report by the senate labor committee and by a report issued this past april by consumer

voice. for solutions can what would recommend is implementing with virtually all commenters on all sides of this issue agree on, that non-pharmacological approaches should be tried first pick to achieve that in we recommend a number of approaches that would call prescribes attention to the issue of antipsychotic drug use, slow down the process of prescribing these drugs, teach better nondrug alternatives, and create an imposed stronger sanctions or inappropriate use. finally, i want to describe what eliminating antipsychotic drugs can mean for individual residents. a researcher working in new york to try to translate the research literature into practice at nursing homes sent me an e-mail about a small facilities she has spoken with. she said the director of nursing heard her speak and osha been skeptical, she involved in medical director consultant pharmacist and you're left with only two residents using antipsychotic drugs, both with a diagnosis of schizophrenia.

then this is what she said. one man they found had severe back pain from a spinal injury from a car accident years ago that was never addressed. it is dementia prevented is communicating the pain and they had any deep seeded jiri chair which only exacerbate pain, the poor man. so you behavior issues amazon anti-psychotic meds, couldn't communicate or feed himself. now he eats lunch at a diner and traverses with his wife, participate in activities, et cetera. if taken with antipsychotics and replace with pain medication. one story makes it all with the. i would add that this story could be replicated hundreds of thousands of times in nursing homes across the country, drastically reducing the use of antipsychotic drugs would improve the lives of residents of hundreds of thousands of residents and save hundreds of millions if not billions of dollars but after 35 years of study and reports in here, it's time to eliminate the epidemic use of antipsychotic drugs. thank you, sir. >> thank you, ms. edelman. dr. phillips.

>> thank you, chairman kohl. and thank you for addressing this article is yet for involving all of us as witnesses because there is an important story to be told you. and we appreciate it. as when a backer my name is cheryl phillips and a fellowship trained geriatrician and i like my friend and colleague has been several decades in critical practice predominately in the long-term or study but i do have the privilege of being the senior vice president. the 5700 members of leaving age serve as nearly killing people a day through their mission driven not-for-profit organization that offer a spectrum of services across the post-acute and long-term care continue. and together we dance policies, promote practice, connect research support, enable and empower people to live as fully as they can. so not only do we embrace this issue as a critical, important

platform, we're going to talk a lot about how both are members, are participating in how we are offering some solution. we've heard about the demographics. it's worth noting as seniors eight years or older with a diagnosis of dementia, 75% will spend time in long-term care setting. so this is an important and relevant platform conversation. and even by cms's own reports, 50 to 75% of long-standing nursing home residents have some degree of dementia. but as i say that, it's important to know that this is neither just a nursing home issue, nor just a u.s. issue. part of my testimony i include some materials that were shared from the united kingdom and looked out the medication use and appropriate care of dementia across hospitals, outpatient and nursing home settings. and gave 11 recommendations that i think, despite the large pool of water between our two

countries have a lot of application that we can take and use in our thinking today. so i would start with the use, and we've mentioned it but it's worth noting again, the use of antipsychotics is related to a much larger chunk of how to best care for people with dementia. medications are most often used as a first line of option because, quite frankly, families, caregivers, nurses, doctors across all settings of care are not aware and don't even know of alternatives. they do believe that they are doing the right thing for the person that they love or the person they are caring for. i'll also add just a note of caution. if we merely target this as a one class of drugs in one setting we may have some unintended consequences. for instance, if we look at just one narrow scope of drug, what will happen is prescribers will then shift to other equally inappropriate drugs such as sedatives, hypnotics, and off label use of anti-seizure

medicines, all of these which also carry a risk of false confusion and death. so it's bigger than a drug problem, although the drug becomes a tip of the iceberg of what the underlying issue is. we've also a dress that is not just a nursing home problem. if we focus just on the solutions in the nursing home, i do caution we don't create inappropriate barriers to access for people who desperately need appropriate nursing home care. so i think that the short-term solution is, in fact, not a short-term solution but a twofold strategy that ties into a longer, sustained cultural change. verse is the application of nonpharmacologic interventions. we talk about behavior therapies. and second is when medications, the close monitoring and limited use. we have heard from a cms that there are existing regulations. i won't go over them again. i will still then because when i worked with my own patience and with staff and nursing homes, we

really narrowed it down to five simple question. what is the specific indication? not why you want use the drug but what is the valid indication. if there was an appropriate indication, this is to appropriate now? may be the issue was a day ago, a week ago, the transition has happened, the agitation has result, the pain has been more appropriate addressed but if the person is on an anti-psychotic, is it working? is what you're trying to address, have you documented it effectiveness? i'll just the stand, is the person better able to function in there if i'm on the medicines that off? has the family or caregiver involved in a choice, are they aware of the indications, the risks and potential benefits, and had he been engaged in the discussion? and is there a history of appropriate nonfarm logical intervention and less there was a short-term emergency? if the answer to any of these is no orono, and the medication should not be started or discontinued. the long-term answer because we

know that d. with the meds alone is not the solution is much like i would look at physical restraint reduction that my colleague toby refer to pick it comes from a sustained campaign where caregivers focus on real person centered care alternatives, including direct workforce training with evidence-based tools, dissemination of knowledge regarding to effectiveness of nonpharmacologic interventions. and an interdisciplinary team true monitoring and medications are used to ensure appropriate indication those duration in response. this will all take a collaborative partnership. it includes cms staff, physicians across the health care continue to not just in the nursing home. pharmacist, director workforce and caregivers. we need accurate data to look at timely information to speed back to subscribe to we large-scale research to look at how these models can be disseminated widely with certain need in his survey or training as a smidge. and we need investment and meaningful workforce.

we at leading edge talk up some solutions, get a not-for-profit difference. we can be the workgroup already looking at exciting models but a couple that i will mention, allies and jennings in cleveland, minnesota, taking that same philosophy of medication free treatment to dementia, working through a remarkably hate your interventions and alternate. and lastly i want to acknowledge that leading age is a co-convener of advancing excellence that represents truly a multi-stakeholder coalition that is committed to improving quality care for life, for people in nursing homes. so in summary, yes, we have a significant problem within an appropriate use. the solution is how we better take care of persons with dementia which includes focusing on dignity, compassion, having across the board approach that involves direct caregivers, staff, prescribers, physicians, nurses, and families and their loved ones, as all part of the caregiver team.

and we set the challenge that i could nursing homes should not be the problem but we believe they can be the centers of excellence for improving dementia care. and a learning laboratory for the rest of the health care setting. thank you very much. >> thank you very much, dr. phillips. dr. evans. >> you argue that using and as regards for patients with dementia should only occur as a last resort. and only when all other interventions have been tried and failed. off and your experience to behavioral interventions fail. what is your estimate of how, antipsychotics would be used if health care professionals were trained and deployed a range of behavioral interventions? >> well, as was mentioned earlier, in so many words, if all you have is a hammer everything looks like a nail, that's the problem that we're dealing with now.

as i mentioned in my testimony i don't use these drugs to treat behavior. these drugs, study after study can have shown are ineffective in treating behavior, and i believe that if appropriate steps were taken, or even if they were not taken, that the use of these medications could be reduced to pretty close to zero. and in a variety of settings. that being said, because only a small proportion of the use of these medications happens in nursing homes, it may not have a huge impact that you're hoping for. $8 billion is spent on off label use of these drugs currently are year, and based on the oig report, less than a fourth of that is nursing homes. >> so what is your answer quickly. given. >> my answer is close to zero.

>> zero? >> yes. in my personal practice is zero. other doctors will give you a different number, but there's so many other things that can be done that, you know, really does not represent good dementia care. >> thank you. mr. hlavacek, mr. peterson's tragic death seems to be a wakeup call for the need to find better ways to provide care for individuals with dementia. the alzheimer's community in wisconsin, we can prevent others from suffering the same misfortune. and how can we here in washington help to promote these training programs? >> there are several answers to question, senator. we have to national programs. the foundation of dementia care, which is sort of the classroom

approach for direct care staff and supervisors. and we have the online cares program which has a number of modules that are designed to train on a number of different facets of quality care. and the person from leading edge was absolutely correct. this is a problem that is in the middle of a bigger set of problems. it's nested within a number of other pop around quality care. we certainly believe that staff training and education is critical. we think it should happen at all levels of the facility. certainly for the cna's as seen in the affordable care act, but really often times it's a janitor pick it someone else in the facility that picks up on behaviors earlier and said something is wrong with that gentleman down in that hallway, we should check this out. and not wait for the problem to take place further your on our chapter level with a 16 our dementia care specialist training, which is highly in demand across wisconsin.

in many of these cases, we see through the application of these training programs that they have new tools the on just the hammer and a nail, to address some of these difficult issues. a further problem though, just a complicated is a little bit is staff turnover in these facilities which is very, very rampant. you can go back to the same facility that you trained in a year later and see a sea of fresh faces that weren't there before because of staff turnover. so we don't really value the position and these jobs to hide in our society. we need to perhaps look about as why aren't we provide a better standard of living for the people working in the facilities. >> thank you very much, mr. levinson. the gentleman, what type of staff training would you recommend that cms required to help curb the overuse i should have had a psychotic in nursing homes, and should similar

training be provided also in assisted living facilities, hospitals, as well as other health care settings? >> training would be extremely important. i think we could have a model that we had with physical restraints when the reform law was first implemented in 1990. cms did a lot of training about how to remove physical restraints. it was in person training that i attended. now cms does a lot of training with satellite broadcast. they can do that. it can send out the word, trying all kinds of people all over the country come in better care practices. one of the organizations that i've been working with very close on the as a psychotic drug issue is california advocates for nursing home reform. they are conducted a series of trainings in the state. they had one a week or so ago with several hundred nursing home residents -- nursing staff neighbors and they're having people who have done what dr. evans described. not provide care to people with dementia, providing care to them

without chemical restraints, and having people who have done it teach other facilities have to do it. it's very effective. it's worked with physical restraint and it should work with chemical restraints as well. >> that's good, thank you. dr. phillips, hospitals and nursing homes working together to reduce the rate of anapestic argues, and if they are not, leading edge commit to helping to make this happen? >> the short answer is no. and that's unfortunate. there is a chasm between hospitals and nursing homes. in a variety of problems. and i think appropriate care to mention is but one of them. the opportunity certainly to some of the new models of integrated care provisions is an excellent starting point. it will take more than leadingage alone and that's why we are working so closely with collaborators such as through advancing excellence. because we recognize that as we

provide a basis of both the learned, let's learn some people are doing it well and how to replicate it, but also to inform the clinicians across the continuum that there are valid and real alternatives. lastly, i want to put an important issue, we talked about steph turner with the alzheimer's association. one thing that advancing excellence has a different is that when you have existing staffing, so that the same person as often as possible taking care of that same residents, the behavior issues also tended to decline. so that's another area that with we at leadingage working with advancing excellence are working on better understanding of staff turnover but also staff consistency, as probably a key quality measure. and that relates to false, pressure ulcers, inserting to behavior management in pursuit with dementia. >> dr. evans, you talked about informed consent. do you believe the best family members of dementia patients

understand that off-label use of difficult antipsychotic drugs can be quite harmful? and if not, what can we do to ensure that family members understand the risks of these drugs for their loved ones who cannot communicate their needs clearly and who are thought to have behavior problems? >> sir, and the process of informed consent very seldom occurs in prescription and in administration of these medications in any setting when treating behavior. part of the reason for that is that the use of these medications very often represents a great deal of frustration and caregiver stress, whether it's in the hospital or nursing home or elsewhere your and there is a, sort of a fantasy really that if

some out there which is a magic pill that would make it go away, and that all would be well. and so oftentimes these drugs are initiated in kind of a crisis situation, where it's considered why the people involved to be urgent and, therefore, oftentimes family members are not notified. i think that, in that particular situation, really what's going on is these medicines and others like them, other classes of drugs that dr. phillips talked about already being used as an equalizer's. -- as tranquilizers. there really are not diseases that i know of that only occur on one shift or on saturdays only, or, you know, in between,

when they are getting a report of the house or something like that, you know, the pattern under which these crises develop often are related to other things going on in the environment. and, frankly, i think of this problem that we're talking about, the same way that i think about, it's been used everywhere based on what may be a one time seemed like a good idea, but now we know it's harmful and we have to get rid of it and it's rather expensive proposition. but informed consent at least includes patients and families in the discussion. i mean, it's one of the fundamental bases, one of the most basic ethical principles about care in this country, and autonomy. and so unit, i really can't defend not getting patient's permission to be provided

treatment. certainly we wouldn't stand for that if it was a surgery. but the risks we are talking about of comparable magnitude. having informed consent is part of the process. in some ways allow for a little bit of a cooling off period as well in those conversations should happen in the light of day. but, you know, the reality is that was easy and convenient is what gets done. and substantial and enduring change requires changing what seems to be inconvenient. >> thank you. this adelman, your test for notes that 40% of nursing residents are considered to be at high risk of receiving an atypical antipsychotic drug to to behavior problems which, of course, is an astonishing high number. is there evidence that behavior

province of some how, worse over time? >> i don't know that we have any evidence that behavior problems have gotten worse. i think that residents have behavior issues and there's not staff there that knows the resin and knows how to deal with them. if the general recognition that nursing homes are understaffed and so you are not dealing with problems as well as they might. i think nursing homes may be to have residents who are more seriously ill than before we do have failed the alternative of assisted living now, where some people with lesser problems may be living but although they're beginning to look more and more like nursing home residents all the time, and i've seen some reports indicating that they take more drugs than nursing home residents. so it's hard to say. i think there are issues that people have come and they are not being dealt with properly. that's probably the primary

concern. >> doctor fields comedy want to come a? >> i will add that just on the clinical history of dementia, usually the behaviors when they are problematic our face it. so early on in the disease process not so much, somewhere in the middle phase and not for everyone, and usually by outside what i mean outside to the person, trigger events, either too much noise or fatigue or pain or other medical problems, something that creates an education. but quite frankly, in fact most commonly in advanced dementia the behaviors fade away if not disappear entirely. so even if one argued that occasion the medications are appropriate for short-term use, another piece to this problem is it's like particles. once people are on these medicines they don't come off. they tend to just stay on and to move from setting to setting with these medicines as part of their package, if you will. so we think of them is not just

behaviors get worse over time, in fact they may be worse somewhere in the middle of the persons clinical courts with dementia. but not everyone with dementia has difficult behaviors, and certainly the vast majority of difficult behaviors are triggered and, therefore, resolved by outside environmental issues that can be much better addressed through intervention rather than pills. >> dr. phillips, are the safer medications and antipsychotics for individuals with dementia who are in pain? and if so, what are they? >> well, to address specifically pain, we have another issue in the nursing him that i know you're very familiar with and is the appropriate treatment of pain for nursing home residents. it has been noted by several studies that even the use of medications with morphine when people are in pain, their confusion gets better if the confusion was due to untreated pain. what i'm cautious and i'd mention early and unintended

consequences if we don't substitute antipsychotics for other inappropriate drugs. but having said that, sometimes the very best management for a person who is acutely agitated who cannot give us their story through words is to look and see is paying the underlying problem and treat within. in fact, some nursing homes have now routinely looked at low-dose medicines like acetaminophen to use in persons like to mention who have risk for paint to see if that doesn't rather than wait for their behaviors to escalate if that doesn't modulate some of the agitation underlying. now, i'm serving up reporting that we just give medicines willy-nilly to everybody without being very careful about what is the appropriate indication for any medicine, including pain medicine. but part of one piece to this problem is that when we don't of properly treat pain we see a result in increased agitation and what we label as difficult behaviors in persons with

dementia. >> ms. edelman? >> may i say something? the researchers that a doctor at the end of my testimony in new york has done work. i'll try to get a copy of this incident for the record. she has looked at residents who had dementia and whether they get as much pain medication as residents without dementia with the same physical diagnoses, to say medical problems, and she has found that they don't get as much pain medication as non-dementia residents get. so that's a very strong indication that a lot of the problem is that people are in pain and it's not being treated properly because it hasn't been identified. cms is trying to fix that. the newest assessment process, which has now been in for about a year, a little over a year, has changed the way facilities assess residents paint. in the past, stafford and whether they got residents were in pain. now, the staff is asking residents if they are in danger the numbers should really be

considerably higher than we've seen before because most people think that maybe 50, 60%, 70% of residents have some pain problem. so if that gets identified and treated, there might be, this could really be a very important way of getting around all its antipsychotic drug use. because the residents are in pain and it's not being identified and treated. i will give that article. >> yes, please submit it to us. >> any comments you wish to make to this panel? >> well, once again thank you so much for holding this hearing. one of the things that was touched upon was the whole concept of care transitions. and i think that's a very important piece for the committee to consider going into the future. we have definitely seen a break-in into medications in our task force between hospitals and nursing homes and assisted living facilities. people get transferred out of the facility and into a

hospital. deadhead me close behind individual, the hospital may have a really difficult time getting the person placed back someplace in the community that is appropriate. and the hospital on the other hand may say we send them back to the facility and they show up back here again in a few days, and we can't have it happen because of the medicare reignition rules. so i think that looking at those care tried nation -- in light of this particular issue would be very informative because of the fact that our experiences, that is one place where the use of those medications can truly escalate. we've heard nursing homes say they come back from a hospital and there on more medications than we know what to do with. and we've heard hospitals say, when they come here there are 12 different medications, how does the nursing home allow that to happen? so it's a complex issue but i think there's a lot of room for both hospitals and nursing homes and long-term care facilities, i'm including assisted living, to have a strong vested

self-interest in fixing that problem. it doesn't work for anybody. so i think that would be a great area for further development of policy and collaborations and best practice models. >> that's a good comment, thank you. anybody else like to add to this very informative discussion? >> if i could just add, you know, we have a huge problem in this country with extraordinarily expensive care, and significant concerns about health care quality, such as at we are not getting our money's worth. doctors, unfortunately, as this hearing described, have a share, a large share of responsibly for many other problems that problems that exist in health care, particularly with regard to prescribing medications.

and i believe that doctors have a responsibility to be part of the solution. my colleagues and i are very committed to solving this problem. i also would just like to say that good care really shouldn't depend in this country on where you go to get it. people should have a reasonable expectation of good care anywhere and everywhere, whether it's a hospital, a nursing home, and office, and so it's my hope that in my lifetime that i will see the standard of care being applied really equally across all care settings, and things that have been shown to be successful and effective in one setting apply to other settings. >> thank you, dr. evans. ms. edelman? >> yes.

things as important as training is, and i think it's important for facilities to be trained and prescribes to be trained, it's also important that cms strengthened a little bit the very excellent regulations that it all rehouse, and the guidelines. but that they put some attention on. so is each survey made sure to include in the resident samples, visit with antipsychotic drugs really focus attention on this issue, it would be very helpful. and if the enforcement could be strengthened. i read a couple of decisions from the administrative law judges were unnecessary drugs, antipsychotic drugs, have been cited, but the civil money penalty was $300 a day. so $3900 penalty for over medicating a resident seems like a very inadequate penalty. and, finally, i think they're a couple of laws and regulations that could help strengthen what we have is a very excellent base of law and regulation.

section seven of the prescription drug cost reduction act that you introduced last month would require physicians certification, that the off-label prescription of an antipsychotic drug is form medically accepted indication. that would be very important but we would really hope that that would get enacted. cms recently proposed and many the consultant pharmacist regulations to make sure that they are independent. that's very important to independent consultant pharmacist can make an enormous difference and call to the physicians attention that there's a problem with the prescribing of the drugs. the physicians are required to respond to the irregularities. not that they had to keep records but they are required to respond. and, finally, in 1992, cms proposed very comprehensive regulation on chemical restraints, which would strengthen the requirements on the informed consent. those regulations have never been issued in final form, and we encourage cms to do that as well. >> thank you.

thank you all very much for being here. this was obvious a very important issue, and you did shine a lot of light as we move forward to improve. thank you so much. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations]

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