Medication Therapy Management Empowerment Act of 2011

Mr. President, today I rise to reintroduce the whistleblower Protection Enhancement Act. I am pleased that Senators Collins, Grassley, Lieberman, Levin, Carper, Leahy, Harkin, Pryor, Landrieu, McCaskill, Tester, Begich, and Cardin have joined as cosponsors of this bill.

The need for stronger whistleblower protections is clear. As we slowly recover from the deepest recession since the Great Depression, and grapple with unsustainable budget deficits, we cannot wait to act on measures to make sure the government uses taxpayer money efficiently and effectively.

This legislation will help us hold those who manage the public's dollars accountable by strengthening protections for Federal employees who shed light on government waste, fraud, and abuse. Studies have shown that employee whistleblowers are responsible for uncovering more fraud than auditors, internal compliance officers, and law enforcement officials combined. As an example of the type of disclosures we need to encourage, in one of the few cases in which a whistleblower prevailed, an Internal Revenue Service manager disclosed alleged fraud and preferential treatment of certain wealthy and influential taxpayers. The Merit Systems Protection Board denied his claim, but five years after the whistleblower retaliation occurred, the Court of Appeals reversed. Ensuring that dedicated civil servants can come forward and report wrongdoing without facing retaliation is an important step for saving taxpayer dollars, reducing the deficit, and improving our country's long-term economic health.

Our bill also will contribute to public health and safety, civil rights and civil liberties, national security, and other critical interests. Federal employees may be the only people in the position to observe a problem with a drug safety trial, a cover up of violations during a food inspection, overreach in Federal law enforcement, or safety concerns at a nuclear plant. But few employees will have the courage to disclose Federal Government wrongdoing, which can affect every aspect of government operations, without meaningful whistleblower protections.

The Whistleblower Protection Act, WPA, was intended to shield Federal whistleblowers from retaliation, but the Court of Appeals or the Federal Circuit and the Merit Systems Protection Board repeatedly have issued decisions that misconstrue the WPA and scale back its protections. Federal whistleblowers have prevailed on the merits of their claims before the Federal Circuit which has sole jurisdiction over Federal employee whistleblower appeals, only three times in hundreds of cases since 1994. correction is urgently needed.

Our bill would eliminate a number of restrictions that the Federal Circuit has read into the law regarding when disclosures are covered by the WPA. Because of the Federal Circuit's restrictive reading of the WPA, it would establish a pilot program to allow multi-circuit review for 5 years, and would require a Government Accountability Office review of that change 40 months after enactment. This bill would also bar agencies from revoking an employee's security clearance in retaliation for whistleblowing.

Additionally, this bill expands coverage to new groups of whistleblowers. This bill would expand the coverage of the Whistleblower Protection Act to include employees of the Transportation Security Administration. Intelligence Community employees for the first time would be protected as well, with an administrative process modeled on the protections for Federal Bureau of Investigations employees. Moreover, it would make clear that whistleblowers who disclose censorship of scientific information that could lead to gross government waste or mismanagement, danger to public health or safety, or a violation of law are protected.

I have been a long-time proponent of strengthening oversight by protecting Federal whistleblowers. Last Congress, my Whistleblower Protection Enhancement Act, S. 372, passed both the Senate and the House of Representatives by unanimous consent in December 2010. In the 110th Congress, my bill, the Federal Employee Protection of Disclosures Act, S. 274, passed the Senate by unanimous consent in December 2007, and a similar bill, H.R. 985, also passed in the House of Representatives in March 2008. Unfortunately, both times, we were not able to reconcile the two bills and enact whistleblower protections before the Congress adjourned. I intend to finish the job this Congress. Whistleblowers simply cannot wait any longer.

Congress has a duty to provide strong protections for Federal whistleblowers. Only when Federal employees are confident that they will not face retaliation will they feel comfortable coming forward to disclose information that can be used to improve government operations, our national security, and the health of our citizens. I urge my colleagues to support this legislation.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, this weekend I know that Marylanders will be taking advantage of Passport Day this Saturday, April 9. During these weekend hours at our passport acceptance facilities in Maryland, my constituents will have the ability to renew their passports or apply for a new passport, as we get ready for the summer travel season.

When Marylanders apply for and ultimately receive their passports, I want them to continue to have confidence that the U.S. passport is the gold standard for identification. It certifies

an individual's identity and U.S. citizenship, and allows the passport holder to travel in and out of the United States and to foreign countries. It allows the passport holder to obtain further identification documents, and to set up bank accounts.

The U.S. Government simply cannot allow U.S. passports to be issued in this country on the basis of fraudulent documents. There is too much at stake. Unfortunately, hearings that I have chaired in the last Congress have convinced me that we have serious vulnerabilities in our passport issuance process that need to be closed quickly.

Nearly two years ago, on May 5, 2009, I chaired a Judiciary Terrorism Subcommittee hearing entitled ``The Passport Issuance Process: Closing the Door to Fraud.'' During the hearing last year, we learned about a Government Accountability Office, GAO, undercover investigation that had been requested by Senators Kyl and Feinstein to test the effectiveness of the passport issuance process, and to determine whether malicious individuals such as terrorists, spies, or other criminals could use counterfeit documents to obtain a genuine U.S. passport. What we learned from GAO was that ``terrorists or criminals could steal an American citizen's identity, use basic counterfeiting skills to create fraudulent documents for that identity, and obtain a genuine U.S. passport.'' But that 2009 GAO report was not the first time that problems with the passport issuance process were identified. In 2005 and 2007, GAO also brought these issues to light.

Vulnerabilities in the passport issuance process are very serious because it can have a profound impact on the national security of the United States.

A new GAO undercover investigation that I requested, along with Senators Kyl, Feinstein, Lieberman and Collins, also revealed that while some improvements have been made by the State Department, the passport issuance process is still susceptible to fraud. A Judiciary Terrorism Subcommittee hearing that I chaired in July of 2010 revealed that the State Department issued five additional passports on the basis of fraudulent identity documents that had been submitted by undercover GAO agents.

As a result, today I am reintroducing the Passport Identity Verification Act, or PIVA. This legislation is co-sponsored by Senators Feinstein, Lieberman, and Kerry. It is a common-sense solution that will give the State Department the legal authorities that it needs to access relevant information contained in federal, state, and other databases that can be used to verify the identity of every passport applicant, and to detect passport fraud, without extending the time that the State Department takes to approve passports. The legislation also requires the State Department to promulgate regulations to limit access to this information, and to ensure that personnel involved in the passport issuance process only access this information for authorized purposes. These are very important privacy and security protections in this legislation.

The legislation also requires the Secretary of State to conduct a formal study examining whether biometric information and technology can be used to enhance the ability to verify the identity of a passport applicant and to detect passport fraud.

I understand that the American people can become concerned when their travel plans, whether for leisure or business, are linked to their ability to obtain a passport in a timely fashion. My legislation would not lengthen the average amount of time it takes U.S. citizens to obtain passports. We have got to get this right, and it is not simply a question of process, techniques, and training. We need to make sure that the agencies that are responsible for processing passport application documents are concerned about national security as well as customer service, and we need to make sure they have the legal authorities, the resources, and the technology they need to verify the identity of a passport applicant and to detect passport fraud.

We already have much of the technology and the information to prevent such issuance of genuine U.S. passports based on fraudulent documents or information. The Passport Identity Verification Act will dramatically improve the State Department's ability to detect passport fraud, and strengthen the integrity of every American's passport.

Mr. President, today, I am proud to reintroduce the Medication Therapy Management, MTM, Empowerment Act of 2011, with my colleagues from Minnesota, Senator Franken, from Ohio, Senator Brown, and from South Dakota, Senator Johnson.

A recent analysis conducted by the New England Healthcare Institute estimates that the overall cost of medication nonadherence is as much as $290 billion per year. According to a recent article published in the New England Journal of Medicine, over $100 billion is spent annually on avoidable hospitalizations because patients do not take their medications correctly.

Not only does nonadherence cost our system billions of dollars, nonadherence to medication regimens also affects the quality of life for seniors and may lead to early death. The elderly typically take many more prescription medicines than the general population and therefore are at greater risk for problems associated with improper use of medications. For example, the same New England Journal of Medicine article I just referenced found that better adherence to antihypertensive treatment alone could prevent 89,000 premature deaths in the U.S. annually.

With as much as one half of all patients in the U.S. not following their doctors' orders regarding their medications, medication therapy management could help reduce some of the wasted health care costs in our system.

North Carolina has implemented some very successful MTM programs.

The Asheville Project, which focuses on diabetes, asthma, and cardiovascular disease, has seen improved

health outcomes and significant savings among city employees since it began in 1997. For example, in the Asheville Project's diabetes MTM Project, they have seen a decrease in medical costs of between $1,622 to $3,356 per patient per year; a decrease in insurance claims of $2,704 per patient in year one and a $6,502 decrease in year five; a 50 percent decrease in use of sick days; and increased productivity gains estimated at $18,000 annually.

In 2007, the North Carolina Health and Wellness Trust Fund Commission launched an innovative statewide program, Checkmeds NC, to provide MTM services to North Carolina seniors. During the program's first year, more than 15,000 North Carolina seniors and 285 pharmacists participated. A total of 31,000 seniors have participated since 2007. The seniors bring all of their prescriptions, over-the-counter medicines, vitamins and supplements to the pharmacy to be thoroughly reviewed in a one-on-one session. The pharmacist follows up and educates the patient about his or her medication regimen. The program has saved an estimated $34 million to date, and countless health problems have been avoided.

During consideration of health care reform, I was pleased to have successfully secured language in the bill that built off these North Carolina models and implemented MTM nationally for seniors suffering from two or more chronic conditions.

The bill I am reintroducing today takes MTM one step further. Specifically, this bill would expand MTM eligibility to seniors with any chronic condition that accounts for high spending in our health care system, such as heart failure and diabetes. Currently, only 12.9 percent of Part D beneficiaries are eligible under the MTM criteria for multiple chronic conditions. However, of those, more than 85 percent have chosen to participate in the benefit. Clearly this program is very popular and widely utilized by those who are already eligible. By expanding eligibility to more seniors, MTM will certainly result in Medicare savings.

The bill also ensures access to MTM for seniors at a pharmacy or with a qualified health care provider of their choice.

To ensure pharmacists and health care providers are able to provide MTM to seniors, this bill requires that they are appropriately reimbursed for their time and service. This provision will permit pharmacies and other health care providers to spend considerable time and resources evaluating a person's drug routine and educating them on proper usage--all critical components of a successful MTM program.

Finally, this bill would establish standards for data collection to evaluate and improve the Part D MTM benefit.

The value of MTM is widely known and discussed. I am proud that North Carolina is a leader in this arena. Expansion of MTM to more seniors will no doubt improve their overall health, while at the same time reducing waste in our health care system.

I urge my collegues to support this bill.

Mr. President, today, I am proud to reintroduce the Medication Therapy Management, MTM, Empowerment Act of 2011, with my colleagues from Minnesota, Senator Franken, from Ohio, Senator Brown, and from South Dakota, Senator Johnson.

A recent analysis conducted by the New England Healthcare Institute estimates that the overall cost of medication nonadherence is as much as $290 billion per year. According to a recent article published in the New England Journal of Medicine, over $100 billion is spent annually on avoidable hospitalizations because patients do not take their medications correctly.

Not only does nonadherence cost our system billions of dollars, nonadherence to medication regimens also affects the quality of life for seniors and may lead to early death. The elderly typically take many more prescription medicines than the general population and therefore are at greater risk for problems associated with improper use of medications. For example, the same New England Journal of Medicine article I just referenced found that better adherence to antihypertensive treatment alone could prevent 89,000 premature deaths in the U.S. annually.

With as much as one half of all patients in the U.S. not following their doctors' orders regarding their medications, medication therapy management could help reduce some of the wasted health care costs in our system.

North Carolina has implemented some very successful MTM programs.

The Asheville Project, which focuses on diabetes, asthma, and cardiovascular disease, has seen improved

health outcomes and significant savings among city employees since it began in 1997. For example, in the Asheville Project's diabetes MTM Project, they have seen a decrease in medical costs of between $1,622 to $3,356 per patient per year; a decrease in insurance claims of $2,704 per patient in year one and a $6,502 decrease in year five; a 50 percent decrease in use of sick days; and increased productivity gains estimated at $18,000 annually.

In 2007, the North Carolina Health and Wellness Trust Fund Commission launched an innovative statewide program, Checkmeds NC, to provide MTM services to North Carolina seniors. During the program's first year, more than 15,000 North Carolina seniors and 285 pharmacists participated. A total of 31,000 seniors have participated since 2007. The seniors bring all of their prescriptions, over-the-counter medicines, vitamins and supplements to the pharmacy to be thoroughly reviewed in a one-on-one session. The pharmacist follows up and educates the patient about his or her medication regimen. The program has saved an estimated $34 million to date, and countless health problems have been avoided.

During consideration of health care reform, I was pleased to have successfully secured language in the bill that built off these North Carolina models and implemented MTM nationally for seniors suffering from two or more chronic conditions.

The bill I am reintroducing today takes MTM one step further. Specifically, this bill would expand MTM eligibility to seniors with any chronic condition that accounts for high spending in our health care system, such as heart failure and diabetes. Currently, only 12.9 percent of Part D beneficiaries are eligible under the MTM criteria for multiple chronic conditions. However, of those, more than 85 percent have chosen to participate in the benefit. Clearly this program is very popular and widely utilized by those who are already eligible. By expanding eligibility to more seniors, MTM will certainly result in Medicare savings.

The bill also ensures access to MTM for seniors at a pharmacy or with a qualified health care provider of their choice.

To ensure pharmacists and health care providers are able to provide MTM to seniors, this bill requires that they are appropriately reimbursed for their time and service. This provision will permit pharmacies and other health care providers to spend considerable time and resources evaluating a person's drug routine and educating them on proper usage--all critical components of a successful MTM program.

Finally, this bill would establish standards for data collection to evaluate and improve the Part D MTM benefit.

The value of MTM is widely known and discussed. I am proud that North Carolina is a leader in this arena. Expansion of MTM to more seniors will no doubt improve their overall health, while at the same time reducing waste in our health care system.

I urge my collegues to support this bill.

Mr. President, I rise today to introduce legislation to repeal the tax imposed on medical device manufacturers.

As my colleagues know, this 2.3 percent sales tax imposed on medical device manufacturers--a tax that will ultimately be passed on to consumers--is part-and-parcel of the Federal health care reform bill that passed last Congress.

Like others in this chamber, I am extremely concerned that this tax could threaten jobs in my State, reduce domestic investment in research and development and ultimately diminish access to life-saving medical devices for patients.

Medical technology companies employ more than 375,000 workers in the United States. In Massachusetts alone, we have more than 225 medical device firms, which employ more than 20,000 workers, and contribute nearly $1 billion in payroll. Medical devices are one of our State's top exports, contributing $6 billion to our State's economy.

These are powerfully good numbers. These are the numbers that make my State tick, help drive our economy, and keep people working. I want to make certain that what happens in Washington does not reverse these numbers, does not undermine my State's ability to compete, and does not hamper our chances to grow and hire workers.

Massachusetts' position as an industry leader, a hub of innovation and entrepreneurship must be preserved. That has been and will continue to be my focus in the U.S. Senate.

So how do I intend to accomplish this?

For starters it means working to eliminate the medical device tax, which I believe will diminish our ability to compete, will increase costs for consumers, and could result in our medical device and technology jobs being sent overseas, where the costs of labor and production are cheaper.

The effort that I am spearheading--and that I ask my colleagues to join--eliminates the medical device tax in a way that does not add to the deficit. I propose eliminating this harmful tax--a tax that will stifle innovation, be passed on to consumers, and increase the cost of care--and propose that we offset the cost by using unobligated discretionary dollars. This is the same source of funding, the same offset, that 81 of my colleagues supported yesterday.

As my colleagues know, I worked on an amendment that would repeal the medical device tax last Congress. I will continue this work because the harmful effects of this tax are the last thing Massachusetts needs-- more industry jobs lost, our workers at a competitive disadvantage.

But the medical device tax doesn't just lead to job uncertainty, it leads to investment uncertainty as well, which results in private capital staying on the sidelines rather than being invested in Massachusetts based companies and their workers.

The medical device tax, coupled with other provisions in the Federal health reform bill, increases the level of uncertainty at a time when businesses, consumers and investors are craving the exact opposite.

For example, some medical devices are approved as combination products, both as medical devices and drugs and/or biologics. The Secretary has yet to determine how these medical devices will be captured under the law, how they will be taxed.

I pledge to work with my Senate colleagues--and during the Medical Device User Fee Modernization Act reauthorization slated for next year--to ensure that the medical device companies whose products are approved as combination products by the FDA are not double-taxed by way of the medical device tax and the pharmaceutical tax.

With the rolling implementation of the Federal health care reform bill, this Congress will provide many opportunities for me to protect the interests of and work on behalf of Massachusetts families, Massachusetts taxpayers,

Massachusetts workers, and Massachusetts businesses.

I hope my colleagues will join my efforts to find opportunities to correct what is wrong with the Federal health reform law--to protect innovation, the jobs, and the development and growth that can occur in a sector that is vitally important to our Nation's health.

I know that a robust medical device sector translates into a healthier America--physically, economically, and socially. The same is true for Massachusetts.

Mr. President, on January 25, I introduced S. 149, the FISA Sunsets Extension Act of 2011 to extend the three expiring provisions of the Foreign Intelligence Surveillance Act--the authority to conduct, subject to court order, so-called ``roving wiretaps,'' ``lone wolf'' surveillance, and collection of business records. S. 149 was referred to the Committee on the Judiciary.

Today, I am reintroducing that legislation with a new, identical bill. This new bill, just as S. 149 would do, will extend these three authorities, otherwise set to expire on February 28, to December 31, 2013. The bill will also change the expiration date of the intelligence collection authorities provided in the FISA Amendments Act of 2008 so they, too, last until the end of 2013.

The sole purpose of reintroducing the measure is to begin the process under Senate rule XIV to place the reintroduced extension bill on the Senate calendar. The three provisions of FISA

will sunset in a little more than 3 weeks. One of those weeks is a congressional recess. By placing the extension bill on the Senate calendar, we will, at least, be one procedural step closer to acting.

On January 28, Attorney General Eric Holder and Director of National Intelligence James Clapper wrote to urge Congress to grant a reauthorization of sufficient duration to provide intelligence and law enforcement agencies with reasonable certainty and predictability concerning the tools available to them.

The FISA sunsets have most recently been the subject of two short- term extensions: a 2-month extension from December 31, 2009 to February 28, 2010, and then a 1-year extension from that date to February 28, 2011.

In their January 28 letter, the DNI and the Attorney General expressed their concern about the devolution of FISA sunsets ``into a series of short-term extensions that increase the uncertainties borne by our intelligence and law enforcement agencies in carrying out their missions.''

The letter states that ``S. 149, the FISA Sunsets Extension Act of 2011, would avoid these difficulties by reauthorizing the three expiring provisions until December 2013, together with the provisions of Title VII of FISA that are currently scheduled to sunset next year. We look forward to working with you to ensure the prompt enactment of this or similar legislation.''

Yesterday, the House and Senate Intelligence Committees also received a classified report from the Attorney General and the DNI on the important intelligence collection made possible by authority that is subject to the approaching sunset. The Department of Justice and the Office of the DNI have asked for our assistance in making this classified report available, in a secure setting, directly and personally to any Member of the Senate. We did so for a similar report a year ago when Congress considered the last sunset extension.

Each Senator is invited to read this classified report in the Intelligence Committee's offices in 211 Hart Senate Office Building. The Attorney General and DNI have offered to make Justice Department and intelligence community personnel available to meet with any Member who has questions. Our Intelligence Committee staff is also prepared to meet with Members. Vice Chairman Chambliss and I are sending a Dear Colleague letter to each Senator conveying this invitation.

In concluding, I call upon my colleagues in the Senate and House to heed the Attorney General's and DNI's concern about the uncertainty created by short-term extensions. The 3-year extension that my legislation proposes will give our law enforcement and intelligence officials the tools and certainty they need in protecting the Nation. It will align the several sunsets so that Congress can review FISA more comprehensively in 2013. In setting that date Congress will wisely be separating that review of FISA from the debates of a presidential election.

Mr. President, I ask unanimous consent that a letter of support be printed in the Record.

I am pleased to be joined by Senators Murkowski, Durbin, and Tom Udall in the introduction of the Garrett Lee Smith Memorial Act Reauthorization.

This legislation continues the important work of my former colleague Senator Gordon Smith, who authored the original law, which was named for his 22-year old son, Garrett, who was a student at Utah Valley University when he took his own life. I want to once again recognize Gordon Smith for his work to champion suicide prevention and mental health initiatives.

Currently, this law supports 35 States, 16 Tribes and Tribal organizations, and 38 colleges and universities in their efforts to prevent youth suicide. Indeed, with the help of these important programs, we have made real progress since the 2004 passage of this law in identifying at-risk youth and young adults, providing proven mental health and substance use disorder treatments, and educating the public about youth suicide prevention efforts.

Unfortunately, suicide remains the third leading cause of death for adolescents and young adults age 10 to 24, and results in 4,400 lives lost each year. According to the Centers for Disease Control and Prevention, approximately 150,000 individuals in this age group annually receive medical care for self-inflicted injuries at Emergency Departments across the U.S.

Suicide is particularly prevalent among college-age students as it is the second leading cause of death, resulting in approximately 1,100 deaths each year. The 2010 National Survey of Counseling Center Directors at colleges and universities found that 10.8 percent of students seek counseling each year, an increase of nearly 1 percent from 2009. At the same time, the average ratio of counselors to students has remained constant at one to 1,786.

Many young people who commit suicide have a treatable mental illness, but they don't get the help they need. The legislation we introduced today provides critical resources for prevention and outreach programs to reach at risk youth before it is too late.

It would increase the authorized grant level to States, tribes, and college campuses for the implementation of proven programs and initiatives designed to address mental health and wellness and reduce youth suicide.

Additionally, I am particularly pleased that the bill would enable college counseling centers to have greater flexibility in their use of Federal resources. Counseling centers will continue to be able to apply for funds to operate suicide prevention hotlines and organize educational and awareness efforts about youth suicide prevention; however, with this bill they will also be able to use funds for the provision of counseling services to students and the hiring of appropriately trained personnel. These two components are integral to identifying and treating students who may be at risk with the goal of preventing suicide and attempted suicide on campuses.

Our bipartisan legislation is supported by 43 coalition members of the Mental Health Liaison Group and the American Council on Education.

Mr. President, I unanimous consent that the text of the bill and a letter of support be printed in the Record.

Mr. President, today a bipartisan group of Senators has introduced legislation that would allow the Senate to continue its leadership of our country toward a clean-energy future. Senators Schumer, Alexander, Kerry, Murkowski, Bingaman, and I have introduced a bill that would authorize the Architect of the Capitol to establish battery recharging stations for privately owned vehicles in parking areas under the jurisdiction of the Senate at no net cost to the Federal Government.

Among the most successful job-creation efforts we have undertaken since the financial crisis devastated our economy is our attempt to help American manufacturers create the batteries and other components that will power the next generation of electric-powered vehicles. In my State of Michigan and in other places around the country, the grant program we enacted as part of the Recovery Act has sparked a boom of manufacturing job creation. Given a choice between watching our global competitors create those jobs and creating them in the United States, we have chosen the wiser course.

This has been part of a larger, and largely successful, effort to support the electric revolution in transportation. President Obama's goal of 1 million electric vehicles on the road by 2015 is one part of that effort. He announced last week that by 2015, the government will buy only alternative-energy vehicles for its fleets as part of a strategy to cut U.S. oil imports by 1/3. Such a strategy would help our country economically, protect our environment and enhance our national security.

The legislation we introduce today is another, though smaller, part of that effort. It would ensure that the Senate leads by example as we transition to a clean-energy future. It would establish--at no net cost to the taxpayer--charging stations to power plug-in hybrid electric vehicles. While these vehicles are an important part of our future, they will bring changes in how we think about cars and driving. Instead of looking for gas stations, drivers will need charging stations where they can replenish the batteries that power their vehicles.

The President and others have proposed plans to help encourage the creation of that infrastructure in communities around the country. So should the Senate. This bill would ensure that Senate employees have available the infrastructure to support next-generation vehicles. It would be an important statement of leadership from the Senate. It would provide an example to other employers of how they can support both the needs of their employees and our national interest in energy security.

I am thankful for the support of Senators Schumer, Alexander, Kerry, Murkowski, and Bingaman on this bill, and for the assistance of the staffs of Senators Schumer and Alexander on the Rules Committee. These Senators have recognized the value of Senate leadership in moving our nation toward a future liberated from imported oil, and I hope our other colleagues will as well.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.