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EXAMINING THE REGULATION OF DIAGNOSTIC 

TESTS AND LABORATORY OPERATIONS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

FIRST SESSION 

NOVEMBER 17, 2015 

Serial No. 114–100 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California7 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

DORIS O. MATSUI, California 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 4 

Prepared statement .......................................................................................... 5 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 6 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 8 

Prepared statement .......................................................................................... 9 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

prepared statement .............................................................................................. 65 

Hon. Renee L. Ellmers, a Representative in Congress from the State of 

North Carolina, prepared statement .................................................................. 66 

WITNESSES

Jeffrey Shuren, M.D., Director, Center for Devices and Radiological Health, 

Food and Drug Administration, Department of Health and Human Services ......................................................................................................................... 10 

Prepared statement .......................................................................................... 12 

Answers to submitted questions 1 ................................................................... 84 

Patrick Conway, M.D., Acting Principal Deputy Administrator, Deputy Administrator for Innovation and Quality, and Chief Medical Officer, Centers 

for Medicare and Medicaid Services, Department of Health and Human 

Services ................................................................................................................. 24 

Prepared statement .......................................................................................... 26 

Answers to submitted questions ...................................................................... 85 

SUBMITTED MATERIAL

Discussion Draft, H.R. lll, submitted by Mr. Pitts2

Letter of November 16, 2015, from American Clinical Laboratory Association, 

et al., to the Honorable Lamar Alexandar, et al., submitted by Mr. Pitts ...... 67 

Letter of November 11, 2015, from Action to Cure Kidney Cancer, et al., 

to Mr. Upton, et al., submitted by Mr. Pitts ...................................................... 70 

Letter of November 16, 2015, from Dick Woodruff, Vice President, Federal 

Relations, American Cancer Society Cancer Action Network, to Mr. Upton 

and Mr. Pallone, submitted by Mr. Green ......................................................... 72 

Statement of the Association for Molecular Pathology, November 17, 2015, 

submitted by Mr. Burgess ................................................................................... 74 

Letter of November 16, 2015, from Jan A. Nowak, Clinical Chief of Molecular 

Pathology, Roswell Park Cancer Institute, to Mr. Collins, submitted by 

Mr. Collins ............................................................................................................ 77 

1Dr. Shuren did not answer submitted questions for the record by the time of printing. 

2The discussion draft has been retained in committee files and also is available at http:// 

docs.house.gov/meetings/IF/IF14/20151117/104127/BILLS-114pih-HR————.pdf. 

Page

IV 

Report by the Office of Public Health Strategy and Analysis, Office of the 

Commissioner, Food and Drug Administration, ‘‘The Public Health Evidence 

for FDA Oversight of Laboratory Developed Tests: 20 Case Studies,’’ November 16, 2015, submitted by Mr. Green 3

Letter of November 17, 2015, from David D. Koch, President, American 

Association of Clinical Chemistry, to Mr. Upton, et al., submitted by Mr. 

Burgess ................................................................................................................. 79 

3The report has been retained in committee files and also is available at http:// 

docs.house.gov/meetings/IF/IF14/20151117/104127/HMTG-114-IF14-20151117-SD009.pdf. 

(1) 

EXAMINING THE REGULATION OF DIAGNOSTIC TESTS AND LABORATORY OPERATIONS 

TUESDAY, NOVEMBER 17, 2015 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:03 a.m., in room 

2322, Rayburn House Office Building, Hon. Joseph R. Pitts (chairman of the subcommittee) presiding. 

Members present: Representatives Pitts, Guthrie, Barton, 

Shimkus, Murphy, Burgess, Blackburn, Lance, Griffith, Bilirakis, 

Long, Ellmers, Bucshon, Brooks, Collins, Green, Capps, Butterfield, 

Castor, Schrader, Kennedy, Ca ́ rdenas, and Pallone (ex officio). 

Staff present: Rebecca Card, Assistant Press Secretary; Carly 

McWilliams, Professional Staff Member, Health; Graham Pittman, 

Legislative Clerk; Heidi Stirrup, Health Policy Coordinator; John 

Stone, Counsel, Health; Christine Brennan, Democratic Press Secretary; Jeff Carroll, Democratic Staff Director; Tiffany Guarascio, 

Democratic Deputy Staff Director and Chief Health Advisor; 

Samantha Satchell, Democratic Policy Analyst; and Kimberlee 

Trzeciak, Democratic Health Policy Advisor. 

Mr. PITTS. The subcommittee will come to order. The Chair will 

recognize himself for an opening statement. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Throughout the 21st Century Cures initiative, biomarkers, precision medicine, and targeted therapies were a few of the most consistently uttered terms and concepts. In order to advance each of 

them, we must establish a regulatory environment that fosters the 

development of, and access to, innovative, accurate, and reliable diagnostic testing. Such tests are increasingly important not only in 

diagnosing the onset of a specific disease or condition, but in determining the right course of treatment or procedure. 

It goes without saying that tests providing information to a doctor or consumer are fundamentally different products than traditional medical devices, which actually deliver therapy to, or are implanted in, a patient. Nonetheless, while FDA has used its medical 

device authorities to review and oversee tests developed by outside 

2 

entities that are then sold to laboratories, the agency has not actively regulated laboratory-developed tests, or LDTs. 

Last year, a week after we held a roundtable downstairs that 

highlighted the importance of this very topic, FDA announced that 

it would no longer exercise such enforcement discretion and detailed how the agency proposes to apply its medical device authorities to LDTs. 

Today, I am far less interested in litigating the boundaries of 

current FDA or CMS legal authority, but in hearing from our witnesses how such authority could be clarified or improved, understanding the unique and evolving nature of what is being regulated 

and each agency’s area of expertise. 

In response to a white paper the committee circulated at the end 

of last year asking these very questions, we heard from a number 

of labs and pathologists that FDA should only have a limited role, 

if any, in regulating a select set of tests as medical devices. The 

rest, in their opinion, should be overseen by CMS through an updated Clinical Laboratory Improvement Amendments program. 

This is despite the fact that CMS has stated that they do not have 

the resources, the expertise, or the willingness to take on what is 

being asked of them. I am eager to hear what Dr. Conway has to 

say on this matter. 

We also received comments from a number of manufacturers, as 

well as over 40 patient groups, that FDA, not CMS, needs to be in 

the driver’s seat, and that tests that have the same impact on a 

patient should be held to the same standards, regardless of who 

does the development. This is despite the fact that laboratories are 

uniquely nimble environments where pathologists continually modify and improve tests in ways that manufacturers cannot. 

I am well aware that this has been at times a heated debate with 

passionate advocates on both sides. With such a backdrop, I want 

to particularly commend the manufacturers, the laboratories, and 

other healthcare institutions that have been willing to roll up their 

sleeves and find as much common ground as possible through constructive dialogue, a willingness to compromise, and a pragmatic 

understanding of what a viable, modern framework entails. 

I do not believe that imposing a new regulatory reality on an increasingly important component of our healthcare system via guidance is the best way to address these issues. These products warrant a regulatory system designed with them in mind. They should 

not be shoehorned into a system that was drafted in the 1970s. 

This committee has clearly shown that we are willing and able 

to move complicated, comprehensive, bipartisan legislation. The 

discussion draft the committee circulated, along with the hearing 

notice, is of course not perfect, but it is a serious document based 

on significant consensus, and I would ask that all of the stakeholders out there, including our two distinguished witnesses, help 

us improve it as the process continues. 

With that, I would like to thank Dr. Shuren, a frequent, always 

welcome visitor, as well as Dr. Conway, for their willingness to testify today, and I look forward to working with them on these issues 

going forward. 

[The discussion draft is available at http://docs.house.gov/meetings/IF/IF14/20151117/104127/BILLS-114pih-HR————.pdf.] 

3 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

Throughout the 21st Century Cures initiative, ‘‘biomarkers,’’ ‘‘precision medicine,’’ 

and ‘‘targeted therapies’’ were a few of the most consistently uttered terms and concepts. In order to advance each of them, we must establish a regulatory environment that fosters the development of and access to innovative, accurate and reliable 

diagnostic testing. 

Such tests are increasingly important, not only diagnosing the onset of a specific 

disease or condition, but in determining the right course of treatment or procedure. 

It goes without saying that tests providing information to a doctor or consumer are 

fundamentally different products than traditional medical devices which actually deliver therapy to or are implanted in a patient. Nonetheless, while FDA has used its 

medical device authorities to review and oversee tests developed by outside entities 

that are then sold to laboratories, the agency has not actively regulated laboratory 

developed tests, or LDTs. 

Last year, a week after we held a roundtable downstairs that highlighted the importance of this very topic, FDA announced that it would no longer exercise such 

enforcement discretion and detailed how the agency proposes to apply its medical 

device authorities to LDTs. 

Today, I am far less interested in litigating the boundaries of current FDA or 

CMS legal authority than in hearing from our witnesses about how such authority 

could be clarified or improved, understanding the unique and evolving nature of 

what it is being regulated and each agency’s areas of expertise. 

In response to a white paper the committee circulated at the end of last year asking these very questions, we heard from a number of labs and pathologists that FDA 

should only have a limited role, if any, in regulating a select set of tests as medical 

devices. The rest, in their opinion, should be overseen by CMS, through an updated 

Clinical Laboratory Improvement Amendments program. This is despite the fact 

that CMS has stated that they do not have the resources, the expertise or the willingness to take on what is being asked of them. I am eager to hear what Dr. 

Conway has to say on the matter. 

We also received comments from a number of manufacturers, as well as over forty 

patient groups, that FDA-not CMS-needs to be in the driver’s seat and that tests 

that have the same impact on a patient should be held to the same standards, regardless of who does the development. This is despite the fact that laboratories are 

uniquely nimble environments where pathologists continually modify and improve 

tests in ways that manufacturers cannot. 

I am well aware that this has been, at times, a heated debate with passionate 

advocates on both sides. With such a backdrop, I want to particularly commend the 

manufacturers, laboratories, and other healthcare institutions that have been willing to roll up their sleeves and find as much common ground as possible through 

constructive dialogue, a willingness to compromise, and a pragmatic understanding 

of what a viable, modern framework entails. 

I do not believe imposing a new regulatory reality on an increasingly important 

component of our healthcare system via guidance is the best way to address these 

issues. These products warrant a regulatory system designed with them in mind. 

They should not be shoehorned into a system that was drafted in the 1970s. 

This committee has clearly shown that we are willing and able to move complicated, comprehensive, bipartisan legislation. The discussion draft the committee 

circulated along with the hearing notice is of course not perfect, but it is a serious 

document based on significant consensus. I would ask that all of the stakeholders 

out there, including our two distinguished witnesses, help us improve it as this process continues. 

With that I would like to thank Dr. Shuren-a frequent and always welcome visitor-as well as Dr. Conway, for their willingness to testify today. I look forward to 

working with them on these issues going forward. 

Mr. PITTS. And I now recognize the ranking member, Mr. Green, 

5 minutes for his opening statement. 

4 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman, and thank you for calling 

this hearing today, and I want to welcome our witnesses from the 

FDA and the CMS. 

The role of diagnostic tests in our healthcare system has changed 

dramatically since Congress passed the medical device amendments in 1976 and added in vitro diagnostics to the device definition. It has been almost 4 decades, and the evolution of modern 

medicine and the advancement of science has surpassed what everyone could imagine at the time. The enthusiasm around precision 

medicine is high, and the potential of diagnostics to further transform the treatment of disease is limitless. 

When the FDA first began regulating medical devices, applicable 

regulatory requirements for lab-developed tests, or LDTs, were not 

enforced because they were relatively simple tests, generally combined the local labs, and frequently used for rare conditions. 

Today, LDTs have increased in complexity and availability. They 

are often used to diagnose serious medical conditions, and many 

have major impact on patient care. Not only have LDTs become sophisticated, the role that these tests play in delivery of health care 

has expanded. 

The Centers for Disease Control and Prevention estimated that 

approximately 6.8 billion laboratory tests are administered each 

year. An analysis found that results from the clinical laboratory 

tests influence about 70 percent of healthcare decisions. 

The clinical laboratory amendments of 1988 created minimum 

standards of quality for all clinical labs in the country. The Centers 

for Medicare and Medicaid Services, CMS, has jurisdiction over the 

program, and CLIA has successfully improved the quality of the 

clinical labs in accuracy of testing for nearly 25 years. 

However, under CLIA CMS does not confirm the clinical validation of LDTs, meaning that they do not look as to whether it is a 

particular test accurately that identifies, measures, or predicts the 

absence or the presence of a clinical condition. These known gaps 

in oversight have been a source of concern to this committee and 

to the healthcare community at large. 

Yesterday, the Food and Drug Administration released a report 

that included 20 case studies of problematic tests from labs that 

were following the minimum requirements of CLIA but proposed 

real risk to patients. In an area of so much promise and significance to patient care, the accuracy, reliability, and clinical meaningfulness of all diagnostic tests, regardless of where they are created, must be a top priority for healthcare providers, test developers, regulators, and lawmakers. 

Last year, the FDA issued a draft regulatory framework to phase 

in enforcement regulatory requirements, including premarket review, adverse event reporting for LDTs that pose greater risk to 

patients if their results are not accurate and reliable. And I appreciate FDA’s efforts to ensure that tests are supported by rigorous 

evidence and that patients and healthcare providers can have confidence in their results. 

That said, I share the opinion of my colleagues that legislation 

is both appropriate and necessary to modernize clinical laboratory 

5 

diagnostic oversight. The legislative solution is surely the surest 

way to establish a framework that will be embraced by stakeholders, avoid litigation, extended uncertainty, and foster innovation of new clinical diagnostic tests. 

The FDA’s approach to this draft guidance let to a number of important questions, but the guidance documents also spurred a larger conversation about the overarching need to modernize oversight 

of these unique and increasingly important tests. 

During the 21st Century Cures initiative, as part of the broad effort to close the gap between science of cures and how we regulate 

medical products, the committee hosted a roundtable on precision 

medicine and advances in diagnostic testing. The committee also 

released a white paper on diagnostic test regulation and received 

outpouring of feedback from stakeholders. 

While all parties did not agree on all the principles, much less 

specifics, it was abundantly clear that any regulatory framework 

for diagnostic tests must prioritize patient benefit and allow for 

continued innovation and investment through regulatory certainty 

and appropriate regulatory controls. 

There is urgent need to establish clear and logical lines separating the practice of medicine and the actual conduct of the diagnostic tests and the development and manufacturing of diagnostic 

tests so that the promise of 21st century medicine can be fully realized. 

Today, we will hear from FDA and CMS about each agency’s respective role in the oversight and regulation of clinical laboratory 

tests. Members of the committee will have questions about the appropriate role of each agency and any updated framework, and how 

Congress can best promote robust investment and innovation while 

protecting patient safety. 

Mr. Chairman, I look forward to hearing from our witnesses, and 

I yield back. 

[The prepared statement of Mr. Green follows:] 

PREPARED STATEMENT OF HON. GENE GREEN

Good morning, and thank you all for being here today. 

The role of diagnostic tests in our healthcare system has changed dramatically 

since Congress passed the Medical Device Amendments in 1976 and added in-vitro 

diagnostics to the device definition. 

It has been almost four decades, and the evolution of modern medicine and advancement of science has surpassed what anyone could have imagined at that time. 

The enthusiasm around precision medicine is high, and the potential of 

diagnostics to further transform the treatment of disease is limitless. 

When FDA first began regulating medical devices, applicable regulatory requirements for lab-developed tests or ‘‘LDTs’’ were not enforced because they were relatively simple tests, generally confined to local labs, and frequently used for rare 

conditions. 

Today, LDTs have increased in complexity and availability. They are often used 

to diagnose serious medical conditions, and many have a major impact on patient 

care. 

Not only have LDTs become more sophisticated, the role these tests play in the 

delivery of health care has expanded. 

The Centers for Disease Control and Prevention estimated that approximately 6.8 

billion laboratory tests are administered each year. 

Another analysis found that results from clinical laboratory tests influence around 

70 percent of healthcare decisions. 

The Clinical Laboratory Amendments of 1988 created minimum standards of 

quality for all clinical labs in the country. 

6 

The Centers for Medicare and Medicaid Services (CMS) has jurisdiction over the 

program, and CLIA has successfully improved the quality of clinical labs and accuracy of testing for nearly 25 years. 

However, under CLIA, CMS does not confirm the clinical validity of LDTs, meaning they do not look at whether a particular test accurately identifies, measures, or 

predicts the absence or presence of a clinical condition. 

These known gaps in oversight have been a source of concern to this committee, 

and to the healthcare community at large. 

Yesterday, the Food and Drug Administration (FDA) released a report that included 20 case studies of problematic tests from labs that were following the minimum requirements of CLIA, but posed real risk to patients. 

In an of area so such promise and significance to patient care, the accuracy, reliability and clinical meaningfulness of all diagnostic tests—regardless of where they 

are created—must be a top priority of healthcare providers, test developers, regulators, and lawmakers. 

Last year, the FDA issued a draft regulatory framework to phase in enforcement 

of regulatory requirements, including premarket review and adverse event reporting, for LDTs that pose greater risk to patients if their results are not accurate and 

reliable. 

I appreciate the FDA’s efforts to ensure that tests are supported by rigorous evidence, and that patients and healthcare providers can have confidence in their results. 

That said, I share the opinion of my colleagues that legislation is both appropriate 

and necessary to modernize clinical laboratory diagnostics oversight. 

A legislative solution is the surest way to establish a framework that will be embraced by stakeholders, avoid litigation and extended uncertainty, and foster innovation of new clinical diagnostic tests. 

The FDA’s approach in its draft guidance led to a number of important questions, 

but the guidance documents also spurred a larger conversation about the overarching need to modernize oversight of these unique and increasingly important 

tests. 

During the 21st Century Cures Initiative, as part of the broad effort to close the 

gap between the science of cures and how we regulate medical products, the committee hosted a roundtable on precision medicine and advances in diagnostic testing. 

The committee also released a white paper on diagnostic test regulation, and received an outpouring of feedback from stakeholders. 

While all parties did not agree on all principles, much less specifics, it was abundantly clear that any regulatory framework for diagnostic tests must prioritize patient benefit, and allow for continued innovation and investment through regulatory 

certainty and appropriate regulatory controls. 

There is an urgent need to establish clear and logical lines separating the practice 

of medicine, the actual conducting of a diagnostic test and the development and 

manufacturing of such tests, so that the promise of 21st century medicine can be 

fully realized. 

Today, we will hear from FDA and CMS about each agency’s respective role in 

the oversight and regulation of clinical laboratory testing. 

Members of the committee will have questions about the appropriate role of each 

agency in any updated framework, and how Congress can best promote robust investment and innovation, while protecting patient safety. 

I look forward to hearing from our witnesses and I yield back the balance of my 

time. 

Mr. PITTS. The Chair thanks the gentleman, now recognizes Dr. 

Burgess in lieu of Chairman Upton, 5 minutes. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Mr. Chairman. 

I appreciate the opportunity that we have before us with this 

hearing, but I do want to say at the outset, with everything else 

that is going on, this may be one of the most important and at the 

same time the most frightening concepts that is before the Congress right now. We are talking about a proposal that may not just 

7 

stifle but eliminate medical innovation, something which this country has excelled for decades, and we are also opening the door for 

the first Federal regulation of the practice of medicine, not the needles and IV solutions, the actual diagnostic thought processes that 

go in to practicing medicine. 

Let me just say at the outset I do strongly believe in the potential of genomic medicine. I understand how important it is to really 

understand illness at a molecular level, quickly diagnose it, and get 

the treatment that is appropriate for the patient with a minimal 

amount of side effects. 

A year and a half ago, when the President talked about precision 

medicine during his State of the Union Address, I thought that was 

a very positive development. There are not many places where the 

White House and I agree on anything, but here was some common 

ground, and I took it to heart. 

Laboratory testing produces the informational building blocks 

that are at the heart of precision medicine. As former Administrator Mark McClellan at CMS said, we have got to get the right 

treatment at the right time to the right patient. 

We are not talking about test kits that are put in a box and 

shipped across State lines but medical procedures that are carried 

out by highly trained and qualified health professionals engaged in 

the practice of medicine. 

As we discuss the oversight of laboratory-developed tests, it is 

crucial that we do not slow innovation or create unnecessary regulatory hurdles. We have got to ask ourselves first, what is the problem that we are trying to solve, and is our response appropriate, 

and are there unintended consequences that could result? 

Requiring premarket review by the FDA will impose new and arguably unnecessary requirements and costs on clinical laboratories, 

hospitals, and doctors. Although an additional review of certain 

tests may be warranted, I actually have a greater confidence in a 

CLIA-centric approach, but there are others—and certainly people 

on this committee—who suggested a different track. But it remains 

unclear to me how we can separate the practice of medicine from 

these laboratory processes, and if we cannot, are we effectively 

opening the door to the Federal regulation of the practice of medicine? I reject that notion and believe by segmenting this process 

out has to be the fundamental first step of any proposal. 

Let me just reiterate I do want to be involved in this discussion. 

There is no question in my mind that CLIA can be improved. I was 

not a fan when CLIA came to my medical practice in 1988. I was 

not a fan of having to become a CLIA-certified location. I was not 

a fan of having to apply for a CLIA waiver. But since that time, 

I think arguably you can make the case that CLIA has been a useful enterprise. 

Look, we want doctors and patients to benefit from clinically 

valid tests, and the current FDA proposal, as such, creates regulatory uncertainty that will not be a catalyst for innovation. 

We talk a lot about the Administrative Procedures Act, we talk 

a lot about notice of proposed rulemaking. This is not coming 

through the normal regulatory process. It is coming as a guidance. 

My understanding is to be issued at the end of this year, and like 

it or not, there you have it. 

8 

But, you know, it is hard. On this committee I still retain that 

romantic notion that our Government exists with the consent of the 

governed. In my mind that would not include issuing guidances, 

fiats that are expected to be followed, but rather, you go through 

the normal administrative procedures, hear people out, and make 

the best decision based on the information. 

Thank you, Mr. Chairman. I yield back the balance of my time. 

Mr. PITTS. The Chair thanks the gentleman. 

I now recognize the ranking member of the full committee, Mr. 

Pallone, 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Mr. Chairman. I want to also thank 

Dr. Shuren and Dr. Conway for being here today to discuss the regulation of lab-developed tests. 

There has been a lot of discussion over how to appropriately 

oversee lab-developed tests, and it is important that, as the committee considers this issue, we have a better understanding of the 

strengths and limitations of both FDA and CMS’s authority in this 

area. 

Congress gave FDA authority over lab-developed tests under the 

Medical Device Amendments in 1976, and at that time, most LDTs 

were relatively simple tests used more often for rare conditions. 

Since then, advances in technology and medicine have resulted in 

LDTs that are increasingly more complex, more readily available to 

physicians and patients, and used to diagnose and treat a wider 

range of diseases, including breast cancer and heart disease. LDTs 

are also increasingly used to provide personalized treatment such 

as through genetic tests that help physicians to detect the risk of 

certain diseases earlier or to choose more targeted therapies. 

Unfortunately, many of these tests have not been reviewed or 

cleared by FDA prior to coming to the market to confirm that these 

tests are accurate, reliable, or provide clinically accurate results. 

This can result in patients going undiagnosed with certain medical 

conditions or undergoing treatment that is not medically necessary. 

For example, tests have been developed to identify certain gene 

sequences that can help determine appropriate treatment for ovarian cancer. I am sure many Members here are familiar with the 

example of OvaSure, which claimed to detect early-stage ovarian 

cancer in high-risk women. This test, though, was not properly 

validated and was found to provide high numbers of false positive 

and false negative results, and this means many women who received a false positive result may have undergone unnecessary surgery to remove healthy ovaries, or some women may have gone 

undiagnosed after receiving a false-negative result. 

Patients deserve to know that the test results they are relying 

on to diagnose or treat a condition is accurate, a comfort that they 

do not always have today. And as we have heard from many organizations, patients and their physicians should be able to trust the 

results of their tests, regardless of how or where a test is developed 

or performed. It does not make sense to regulate tests differently 

based on who develops them. 

9 

I also believe that we can provide patients and providers with 

this certainty without endangering or inhibiting the medical innovation that is occurring today. Scientific progress has been made to 

help facilitate the development and use of personalized medicine, 

which you all agree is the future of medicine, but this development 

can only be successful if we know that these complex, sophisticated 

tests are clinically valid. 

So I am glad that today we will have the opportunity to better 

understand FDA and CMS’s authority in this area and hear their 

perspective on what regulatory changes, if any, are needed to address the future development of lab-developed tests. And I hope 

moving forward that both agencies will work with the committee 

on the discussion draft circulated today to ensure that any legislation that moves forward will ensure that LDTs are accurate, reliable, and safe for patients. 

I yield back. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Mr. Chairman, thank you for holding today’s hearing. I also want to thank both 

Dr. Shuren and Dr. Conway for being here today to discuss the regulation of lab 

developed tests. 

There has been much discussion over how to appropriately oversee lab developed 

tests and it is important that as the Committee considers this issue, we have a better understanding of the strengths and limitations of both FDA and CMS’s authority 

in this area. 

Congress gave FDA authority over lab-developed tests under the Medical Device 

Amendments in 1976. At that time, most LDTs were relatively simple tests used 

most often for rare conditions. Since then advances in technology and medicine have 

resulted in LDTs that are increasingly more complex, more readily available to physicians and patients, and used to diagnose and treat a wider range of diseases, including breast cancer and heart disease. LDTs are also increasingly used to provide 

personalized treatments, such as through genetic tests that help physicians to detect 

the risk of certain diseases earlier or to choose more targeted therapies. 

Unfortunately, many of these tests have not been reviewed or cleared by FDA 

prior to coming to the market to confirm that these tests are accurate, reliable, or 

provide clinically accurate results. This can result in patients going undiagnosed 

with certain medical conditions, or undergoing treatment that is not medically necessary. 

For example, tests have been developed to identify certain gene sequences that 

can help determine appropriate treatment for ovarian cancer. I am sure many Members here are familiar with the example of OvaSure, which claimed to detect early 

stage ovarian cancer in high-risk women. This test though was not properly validated and was found to provide high numbers of false-positive and false-negative 

results. This means many women who received a false positive result may have undergone unnecessary surgery to remove healthy ovaries, or some women may have 

gone undiagnosed after receiving a false negative result. 

Patients deserve to know that the test results they are relying on to diagnose or 

treat a condition is accurate, a comfort that they do not always have today. As we 

have heard from many organizations, patients and their physicians should be able 

to trust the results of their tests regardless of how or where a test is developed or 

performed. It does not make sense to regulate tests differently based on who develops them. 

I also believe that we can provide patients and providers with this certainty without endangering or inhibiting the medical innovation that is occurring today. Scientific progress has been made to help facilitate the development and use of personalized medicine, which we all agree is the future of medicine. But this development 

can only be successful if we know that these complex, sophisticated tests are clinically valid. 

I am glad that today we will have the opportunity to better understand FDA and 

CMS’s authority in this area and hear their perspective on what regulatory changes, 

if any, are needed to address the future development of lab-developed tests. I hope 

10 

moving forward that both agencies will work with the Committee on the discussion 

draft circulated today to ensure that any legislation that moves forward will ensure 

that LDTs are accurate, reliable, and safe for patient use. 

I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

As usual, all the written opening statements of the Members will 

be made part of the record. 

That concludes the opening statements. 

I would like to submit under U.C. request the following documents for the record: a November 16 letter from a number of organizations and laboratory directors, and a November 11 letter from 

organizations representing patients, advocates, caregivers, and 

healthcare professionals. 

Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. PITTS. On our panel today we have two witnesses, and I welcome them, thank them for coming. First, Dr. Jeffrey Shuren, Director, Centers for Devices and Radiological Health, Food and Drug 

Administration, Department of Health and Human Services; and 

Dr. Patrick Conway, Deputy Administrator for Innovation and 

Quality, and Chief Medical Officer, Office of the Administrator, 

Centers for Medicare and Medicaid Services, Department of Health 

and Human Services. 

Thank you for coming. Your written testimony will be made part 

of the record. You will each be given 5 minutes to summarize. 

Dr. Shuren, you are recognized for 5 minutes for a summary. 

STATEMENTS OF JEFFREY SHUREN, M.D., DIRECTOR, CENTER 

FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND 

DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND 

HUMAN SERVICES, AND PATRICK CONWAY, M.D, ACTING 

PRINCIPAL DEPUTY ADMINISTRATOR, DEPUTY ADMINISTRATOR FOR INNOVATION AND QUALITY, AND CHIEF MEDICAL OFFICER, CENTERS FOR MEDICARE AND MEDICAID 

SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES 

STATEMENT OF JEFFREY SHUREN 

Dr. SHUREN. Well, thank you, Chairman Pitts, Ranking Member 

Green, members of the subcommittee. Thank you for the opportunity to testify today. 

We are excited about scientific developments in genomics and 

molecular biology that are leading to advances in health care, particularly in precision medicine. Getting the right treatment to the 

right patient at the right time, though, depends upon having accurate, reliable, and clinically valid tests. If not, we give the wrong 

treatment or we give no treatment, and patients get hurt. 

FDA has been regulating in vitro diagnostics for almost 4 decades, and when such a test is made by a laboratory, we call it a 

laboratory-developed test, or LDT. And the law doesn’t distinguish 

on who makes it. We regulate the test regardless of who makes 

that test. And we ensure that those tests are analytically and clinically valid. 

11 

Now, when we first started regulating IVDs, as a matter of policy, we decided not to actively enforce existing requirements on 

LDTs because at the time they were generally simple, low-risk 

tests used on uncommon conditions in often a local setting, typically in a hospital for patients in that hospital. But over time they 

have come increasingly more complex, higher risk, they are used on 

common conditions like heart disease, and they may be offered on 

a national basis. In addition, we have been coming across increasing examples of problematic LDTs. We put out examples of 20 of 

them just yesterday, and there are others. 

As a result of this, the problems we have seen and the increasing 

complexity, there have been calls on the FDA to actively enforce existing requirements that started in the 1990s, NIH and the Department of Energy. In the 2000s two advisory committees to the Secretary of Health and Human Services called on us to regulate. The 

Institute of Medicine has asked us to regulate. 

So in 2007 we put out draft policy to begin to actively regulate 

a subset of LDTs, and what the lab community said is don’t pick 

off tests one by one. Please put in place an overarching framework. 

So in 2010 we had a public meeting to get input, and we were told 

put in place a risk-based phased-in approach. 

And then in response in October of last year we did just that. We 

put out draft policy to now put in place that framework. And what 

we heard from the lab community then, oh, no, there are no problems with LDTs. We don’t need FDA oversight of anything, maybe 

a little beefing up on CLIA, but that is it. 

And now, just a few months ago, we started to see several proposals come out from the lab community that now, for the first 

time, acknowledge that LDTs must demonstrate that they are analytically valid and clinically valid, that they should be subject to 

premarket review, at least moderate- and high-risk tests, the some 

modifications need to be subject to premarket review, that certain 

problems need to be reported to the Government, and they need to 

be under a risk-based approach with a three-tier risk classification 

system. None of those are currently enforced on them today. They 

all exist under an FDA framework. 

But what most of these proposals except one would do is it would 

create a duplicative program under CMS and a bifurcated system, 

leading to more inefficiencies, higher costs, and still putting patients unnecessarily at risk. For example, you can have a conventional manufacturer who makes an IVD we regulated. Now, a laboratory makes a big enough change to it, which laboratories do, 

and it is regulated by CLIA. Then the original manufacturer makes 

a change to that test and it bounces back to the FDA. So we will 

be stuck in a game of regulatory ping-pong, and the real loser here 

is patients. 

Doctors and patients don’t care about who makes a test. They do 

care that their tests are accurate, reliable, and clinically valid. 

Now, some labs have already been working with us, and we congratulate them for crossing that picket line. But our message in 

our invitation to the rest of the lab community is to put down the 

swords, that for the sake of our patients it is time to end the saberrattling and instead partner with us moving forward. 

Thank you. 

12 

[The prepared statement of Dr. Shuren follows:] 

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Mr. PITTS. The Chair thanks the gentleman, now recognizes Dr. 

Conway, 5 minutes for his summary. 

STATEMENT OF PATRICK CONWAY 

Dr. CONWAY. Thank you, Chairman Pitts, Ranking Member 

Green, and members of the committee. Thank you for the opportunity to talk about our work at the Centers for Medicare and Medicaid Services related to ensuring accurate and reliable laboratory 

testing. 

The Clinical Laboratory Improvement Amendments of 1988, commonly referred to as CLIA, of which CMS has primary jurisdiction, 

created minimum standards of quality for all clinical laboratories 

in the United States. CLIA successfully worked for approximately 

25 years and has contributed to major improvements in the quality 

of clinical laboratories, promoted accurate testing, and improved 

patient safety. 

As of July of 2015 there were roughly 250,000 laboratories that 

have registered with CMS and held CLIA certificates. CLIA responsibilities are divided between three agencies: CMS; the Centers for 

Disease Control, or CDC; and the Food and Drug Administration. 

CMS conducts laboratory inspections to make sure that laboratories have appropriate controls, expertise, training, and procedures to ensure that tests are accurate and reliable. CMS also approves accreditation organizations and manages the laboratory certification process. CDC conducts laboratory quality improvement 

studies that guide policy determination and development of laboratory practice guidelines. 

FDA’s primary responsibility under CLIA is to classify clinical 

tests into one of three categories—waived, moderate complexity, 

and high complexity—based on their level of complexity and risk 

to patients. FDA also has a critical role in determining clinical validity of tests and premarket evaluation. Standards that laboratories must meet under CLIA are based on the complexity of the 

tests they perform. Laboratories that perform more complex must 

meet higher standards. 

Laboratories that perform moderate- and high-complexity tests 

must meet requirements on quality assessment, quality control, 

personnel qualifications and education, general laboratory systems, 

and proficiency testing, among others. Laboratories that only perform waived tests, simpler tests that pose a low risk to patients, 

are exempt from most CLIA requirements. In addition, laboratories 

performing the same tests must meet the same standards, whether 

located in a hospital, doctor’s office, or other site. 

This framework is designed to reduce the risk of potential harm 

and ensure patients receive the same high-quality clinical laboratory testing no matter where the test is performed. 

CLIA’s provisions apply to all laboratories in the U.S., not just 

those that receive Medicare payment in order to ensure uniform 

quality across all laboratories. 

CMS enforces CLIA standards by requiring laboratories to obtain 

certificates in order to operate. CMS conducts onsite surveys prior 

to issuing a certificate to a lab that performs high- or moderately 

complex tests. Labs are resurveyed every 2 years, and the surveys 

25 

also assist laboratories in improving patient care through education. 

Laboratories may also receive CLIA certification by obtaining accreditation from one of the seven private nonprofit accreditation organizations approved by CMS. To receive CMS approval, the accreditation organization requirements must meet or exceed CLIA’s 

requirements. 

Moving forward, we believe CLIA and our implementing regulations create the necessary framework to effectively oversee laboratories day-to-day operations and into the future, including those operations that pertain to the use of laboratory-developed tests and 

other high-complexity tests. We have several principles that have 

helped guide our work in CLIA, which may also be useful when informing future efforts of this committee. 

First, we aim to prevent duplicative oversight efforts across agencies. CLIA requires coordination across CMS, FDA, and CDC. We 

have worked to ensure our oversight efforts are consistent and 

complementary and not duplicative. In doing so, we have ensured 

that we take advantage of the unique expertise of each agency and 

its staff. 

Second, we focus on our agency’s oversight strengths. When 

CLIA was implemented in the early 1990s, the responsibility to 

conduct certifications of laboratories was a natural fit for CMS because of our survey and certification experience. On the other 

hand, CMS does not have scientific staff capable of reviewing complex medical and scientific literature in determining clinical validity. This expertise resides within the FDA, which assesses clinical 

validity in the context of premarket reviews and other activities 

aligned with their regulatory efforts under the Food, Drug, and 

Cosmetic Act. 

Third, we value our relationship with our private accreditor organizations and State-based partners. These organizations play an 

important role in evaluating and certifying laboratories. 

Fourth, we take targeted, risk-based approaches to oversight to 

improve patient safety without creating burdensome administrative 

requirements. We believe the current approach in which laboratories must meet higher standards if they are to perform more complex tests has paid dividends in improving the quality of the testing process. 

Finally, as a practicing physician who works clinically on weekends, I know the importance of tests being assessed for clinical validity, as well as the need for assessment for laboratory standards. 

FDA and CMS can work together utilizing their respective authorities and strengths to assess premarket clinical validity and laboratory standards respectively. 

Thank you again for the opportunity to discuss CMS’s work related to ensuring accurate and reliable laboratory testing. I look 

forward to your questions. Thank you. 

[The prepared statement of Dr. Conway follows:] 

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Mr. PITTS. The Chair thanks the gentleman, both witnesses for 

your opening statements. I will begin the questioning. I will recognize myself 5 minutes for that purpose. 

The discussion draft, which the committee circulated before the 

hearing, divides FDA and CMS responsibilities based upon the type 

of activity being conducted by the regulated entity. FDA would regulate test development activities in a risk-based manner, and CMS 

would regulate lab operations. 

Unlike the discussion draft, some alternative proposals being 

floated would divide regulatory oversight between CMS and FDA 

depending on the type of test. 

I would like each of you to respond. Dr. Shuren, would you comment on the implications of an approach that would divide oversight between CMS and FDA based on the type of test, as opposed 

to the type of activity? 

Dr. SHUREN. So such a system is going to lead to inefficiencies. 

It is going to lead to inconsistent standards, treating the same kind 

of test differently depending upon who makes the test. And as a 

result, you can go to one institution, get a test, and it is regulated 

by FDA. You can get the same kind of test across the street and 

it is regulated by CMS. And the people who are put at risk, it is 

patients. 

If we are going to assure that tests work, we need one unified 

system that we are applying consistent standards and we are assuring that those tests are accurate, reliable, and clinically valid. 

Mr. PITTS. Dr. Conway, would you comment on that, the implications of an approach that divides oversight between CMS and FDA 

based on the type of test, as opposed to the type of activity? 

Dr. CONWAY. Yes, I agree with Dr. Shuren. The concern here is 

we want to reduce and avoid duplication and ensure coordination 

across agencies. You know, from a CLIA construct we really are focused on post-market review, laboratory by laboratory, and we are 

really focused on the things such as the protocols in place in the 

laboratory, the equipment and equipment maintenance, the training of staff and personnel. So CLIA’s focus really is on that laboratory-by-laboratory assessment of quality standards. 

Mr. PITTS. And expand a little bit more on whether such an approach would create administrative duplication or any inconsistencies, Dr. Shuren? 

Dr. SHUREN. That is correct. It will create inefficiencies and higher costs because essentially we have duplicative systems in FDA 

and CMS, and the real distinction is just simply who makes the 

test, which doesn’t make sense. And we will have inconsistent 

standards. We can try to coordinate between ourselves, but quite 

frankly, that becomes much more challenging as tests also begin to 

bounce between FDA oversight and CMS oversight. 

Mr. PITTS. OK. Dr. Conway, you stated in your testimony that 

‘‘CMS does not have a scientific staff capable of determining whether a test is difficult to successfully carry out or likely to prove detrimental to a patient if carried out improperly. This expertise resides 

within the FDA.’’ From your perspective at CMS, what would be 

the impact on patients if FDA were precluded from reviewing the 

clinical validity of most LDTs? 

36 

Dr. CONWAY. Yes. So as Dr. Shuren mentioned, I think the challenge is if FDA is not reviewing the test in a premarket manner 

for clinical validity, then our surveyors in CLIA are not assessing 

clinical validity. They are assessing laboratory practices and the 

protocols and standards in those laboratories. So as a practicing 

physician, it is critical, as Dr. Shuren said, that we know that a 

test is clinically valid, meaning it is truly detecting the presence or 

absence of disease. Therefore, the premarket review by FDA is important. 

Mr. PITTS. Now, some stakeholders have said that CMS should 

be tasked with reviewing tests for clinical validity. What are your 

thoughts on that approach? 

Dr. CONWAY. So our survey staff are not trained to assess clinical 

validity, and then let me build on that. Our survey staff are 

trained in laboratory protocols, equipment, standards around those 

protocols, whereas—and Dr. Shuren can certainly speak directly to 

FDA’s staff—is, you know, physicians, Ph.D.’s, biostatisticians who 

are trained in assessing the scientific literature in its entirety and 

assessing clinical validity. 

Mr. PITTS. Now, some stakeholders have suggested that CMS 

should regulate tests developed by labs. FDA should regulate tests 

developed by manufacturers. Some have proposed carving out a 

role for FDA only when a test developer chooses not to publicize 

their methodologies. Shouldn’t the test’s impact on the patient, regardless of who developed it, be the primary factor in developing 

a regulatory framework? Dr. Shuren and then Dr. Conway. 

Dr. SHUREN. Well, we agree that this should be a risk-based 

framework. We also think that you should have one agency that is 

reviewing those tests to assure that they are accurate, reliable, and 

clinically valid. That assures consistency. 

But also, one of the things we have found is when someone 

makes a test, another lab or another entity makes a similar test, 

we learn from that, and we sometimes identify problems or common problems and we are able to feed that back to test developers. 

If you split it between two agencies, we are going to lose all that 

learning that ultimately benefits innovation and benefits patients. 

Mr. PITTS. Dr. Conway, do you want to comment? 

Dr. CONWAY. So I agree with Dr. Shuren. I believe one agency 

doing the premarket review, as Dr. Shuren said, and that agency 

being FDA, makes sense given the training and expertise. We also, 

as you have heard, have a principle of coordination and using each 

agency’s expertise. CMS’s focus and expertise is in the area of laboratory assessment, laboratory by laboratory, on protocols, equipment, et cetera. 

Mr. PITTS. My time is expired. The Chair recognizes the ranking 

member, Mr. Green, 5 minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman. 

I would like to ask unanimous consent to submit a letter from 

the American Cancer Society Cancer Action Network for the record. 

Mr. PITTS. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. GREEN. Dr. Shuren, with other medical devices, FDA has 

proposed regulating lab-developed tests based on the risk of the 

test to the patient and the public. Under proposed FDA would clasVerDate Mar 15 2010 12:10 Aug 03, 2016 Jkt 037690 PO 00000 Frm 00040 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X100DIAGNOSTICSSCANS080216\114X100DIAGNOSTICSPEND
37 

sify LDTs into three risk classes: low, moderate, and high. Can you 

explain how FDA proposes to finding the low, moderate, and high 

risk in the agency’s framework describing how premarket or postmarket requirements would vary among these risk classes? 

Dr. SHUREN. So we look at risk based upon what the risk is to 

patients if that test provides a false result, an incorrect result. And 

we estimate that for low-risk tests we do not conduct premarket review because they are so low risk. We think about 50 percent of 

the tests out there—that has been our experience—are low risk. 

And then we conduct premarket review for high-risk and moderaterisk tests. High-risk tests are only about 1 to 2 percent of the tests 

out there, moderate risk about 48 percent. 

And the data needed to demonstrate analytical and clinical validity differs depending upon the risk of the disease. There is less burden involved when it is a less-riskier test rather that we are reviewing, and that is the risk-based approach that we apply. 

Mr. GREEN. FDA’s approval standard for drugs and medical devices safe and effective, can you just please discuss the approval 

standard FDA has proposed using for the regulation of lab-developed tests? 

Dr. SHUREN. So we would apply the same standard we would 

apply to in vitro diagnostic tests that are not made by a lab, that 

they are analytically valid, they are clinically valid, and they are 

safe to use under their conditions to use. That means they are accurate on what they measure, they are reliable, and they will identify they in fact do identify a disease. 

Mr. GREEN. Companion diagnostics is an area of great interest 

and enthusiasm. Can you talk about how the FDA views this category of tests, in particular the level of risk posed to patients and 

how they would be treated under the proposed guidance? 

Dr. SHUREN. So companion diagnostics are increasingly playing 

a bigger role in health care. Essentially, companion diagnostic is a 

test where the safety and effectiveness of the therapeutic depends 

upon the diagnostic because the diagnostic informs whether or not 

that patient should receive a particular treatment. And that is why 

it is critically important that those tests truly work, because if not, 

then patients are not getting the right treatment or they may be 

getting no treatment at all. 

For example, we had a test for providing treatment for women 

with breast cancer and found that LDTs in the past were producing 

as much as 20 percent of them incorrect or inaccurate results. That 

means that women who should have gotten treated with the right 

treatment were not. And that is preventable. 

Mr. GREEN. OK. Thank you. Dr. Conway, I want to thank you 

also for participating. As you are aware, following the release of the 

FDA’s guidance on enforcing requirements for lab-developed tests, 

a number of stakeholders called for enhancement of CLIA as a 

more appropriate way to regulate the tests. And I appreciate your 

testimony on outlining the difference between FDA and CMS authority over the tests. 

One of the key differences is the fact that under CLIA CMS does 

not review a test for the clinical validity, that is, accuracy on which 

the test identifies measures or predicts the presence and absence 

of a clinical condition or predisposition to a patient. Rather, CMS 

38 

reviews look at analytical validity. You noted that the experience 

and expertise in assessed clinical validity resides instead with the 

FDA. 

Despite CMS stating on more than one occasion that the agency 

does not have the experience or the scientific expertise to assess 

clinical validity in premarket review, many stakeholders continue 

to advocate for additional authority in that area for CMS. Can you 

please discuss further CMS capabilities in implementing regulations for overseeing LDTs, and can you also please comment on 

whether CMS would have the capability of conducting any type of 

premarket review or regulatory review of LDTs? 

Dr. CONWAY. Yes. So our framework that we believe is working 

well now is CLIA is focused on assessment of the protocols, the 

standards, the equipment, the training, and the personnel. Even in 

analytic validity, we are simply looking at, you know, does the lab 

test detect the analyte described? That is very different than clinical validity, which is assessing whether, you know, the test reliably and accurately detects the presence or absence of disease, as 

Dr. Shuren said. 

You know, the majority of our staff are—you know, we have got 

approximately 25 people in the central office running CLIA, a little 

over 100 surveyors across the States, all of the States. They are 

generally medical technologists, former laboratory personnel 

trained to assess laboratory by laboratory. They are not trained to 

assess premarket scientific literature and determine clinical validity. 

Mr. GREEN. OK. Thank you, Mr. Chairman. 

Mr. PITTS. The Chair thanks the gentleman and now recognizes 

the vice chair of the full committee, Mrs. Blackburn, 5 minutes for 

an opening statement. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

Dr. Shuren, looking at the LDT guidance, do you plan to finalize 

that guidance that you issued last year? Do you plan to finalize 

that this year? 

Dr. SHUREN. Yes, we do plan to finalize that. 

Mrs. BLACKBURN. OK. When? 

Dr. SHUREN. In 2016. 

Mrs. BLACKBURN. OK. So basically you are going to put it off another year? 

Dr. SHUREN. I don’t get to determine when, but the plan is to put 

it out in 2016. 

Mrs. BLACKBURN. In 2016. Early or late? 

Dr. SHUREN. Hopefully earlier than later. 

Mrs. BLACKBURN. OK. 

Dr. SHUREN. I wish I could give you an answer. Again, it is so 

far above my pay grade. I don’t even know the people who make 

the decisions. 

Mrs. BLACKBURN. Well, my goodness, we need to have a meetand-greet over at the FDA and see if we can’t get some wheels 

turning over there. We should help with that. 

Let me ask you this. As you finalize that guidance, do you intend 

to use what I think is the outdated 1970s definition of a medical 

device in order to regulate the LDTs? 

39 

Dr. SHUREN. Well, so that definition also includes a distinct definition for in vitro diagnostics, which then incorporates laboratorydeveloped tests. It does not distinguish who makes the tests. 

Mrs. BLACKBURN. OK. Let me ask you this. Each improvement 

in an LDT technology or an upgrade or an update, will that need 

to go back through the medical device approval process? 

Dr. SHUREN. No. Most modifications to tests are not reviewed by 

FDA. We only focus on those that have the really big impact, yes. 

Mrs. BLACKBURN. OK. Do you intend to add to the rapid growth 

of healthcare costs by taxing LDTs as medical devices in addition 

to charging the innovators the user fee? 

Dr. SHUREN. So we are not responsible for administrating the device tax. That is IRS. We have nothing to do with it. 

That said, one of the reasons we put in place that laboratories 

could notify us about their tests as opposed to registering and listing was that it would not trigger the device tax. 

Mrs. BLACKBURN. I think your guidance informs the IRS, though, 

is that not correct? 

Dr. SHUREN. No, the IRS would look separately to if that device 

has listed. 

Mrs. BLACKBURN. OK. I want to thank you for the report that 

you sent to the Congress last night. It was an interesting read. And 

what I found most interesting about it was what was left out and 

that you didn’t discuss the FDA front-end process, which deserves 

some attention and some discussion, specifically the PREDICT program. Twenty-eleven this was put in place. It is a compliance program. It is an artificial intelligence program that is supposed to 

identify high-risk shipments at our ports of entry. And the problem 

with PREDICT is that it is significantly delaying the shipment of 

needed medicine and medical supplies. Medical shipments are often 

sent by express service to get them to patients in time for critical 

usage. And once a shipment is held up by PREDICT, almost all of 

them are subsequently released without any physical inspection. 

So when you look at it from the outside, Dr. Shuren, what it appears to be and the impression is that the bureaucracy of the FDA 

is keeping medicines and medical supplies from patients because of 

concerns that there may have been contamination in some cilantro 

that was in the very same shipment. And I would really like to see 

the FDA spend the effort to fix this before they try to regulate another area of commerce. 

I noticed in that report also that it is based on 20 case studies. 

And how often does the FDA use case studies as sufficient evidence 

to approve or deny a medical therapy? 

Dr. SHUREN. So in terms of approval, we don’t tend to rely on an 

example. We have used a series of case studies as part of support 

for valid scientific evidence as we have approved certain tests or 

other products. 

I will note one thing about the cases, too, we put out yesterday. 

One of the challenges is that we don’t have post-market surveillance in place for laboratory-developed tests as we do for tests 

made by other manufacturers. And as a result, it is very hard to 

identify when problems arise. And yet we know on the IVD side, 

when made by conventional manufacturers, we do detect problems, 

40 

the manufacturers detect problems, and they fix them because that 

is in place. 

One of the other features in the FDA system is the post-market 

surveillance to identify problems and to fix problems, and that is 

just as important as premarket review to prevent faulty tests from 

getting on the market in the first place. 

Mrs. BLACKBURN. Well, as I yield back my time, I hope that you 

will fix PREDICT. I yield back. 

Mr. PITTS. The Chair thanks the gentlelady and now recognizes 

the gentlelady from California, Mrs. Capps, 5 minutes for questions. 

Mrs. CAPPS. Thank you both, each of you, for your testimony, and 

thank you, Mr. Chairman, for putting together this hearing. I appreciate the opportunity to further discuss the strengths and challenges, have a real conversation about laboratory-developed tests 

as they guide medical decision-making by patients and providers. 

There are a lot of question marks and a lot of concern about where 

do we go from here, how do we dovetail these two agencies and giving the best outcome the patients. 

I recognize there are many perspectives in this space. I appreciate this conversation to try to illuminate some of the issues. Over 

the years, it goes without saying these tests have come more tailored and more elaborate, and this conversation is important to ensure that these tests do produce meaningful and reliable results for 

those who trust them. 

Dr. Conway, I will turn to you first. In your testimony you note 

that there are six key performance specification assessments for 

lab-developed tests: accuracy, precision, reference range, reportable 

range, analytic sensitivity, analytic specificity. This committee has 

heard a lot about how different research institutions are driving 

the future of medicine toward more personalized medicine. This 

has been particularly true in the field of cancer where the development of multi-gene panels is being used to identify important molecular characteristics of a tumor. 

And my question to you is whether the current CLIA regulations 

ensure these gene panels developed by different institutions or 

manufacturers will produce the same results? For example, if I am 

a patient and I am tested with hospital A’s gene panel, how do I 

know I would get the same result if I am tested with hospital B’s 

gene panel? Would each hospital reach the same treatment decision, and where does this lead us? 

Dr. CONWAY. Yes, you have highlighted—thank you for the question, and you have highlighted one of the challenges. And Dr. 

Shuren could certainly speak more. 

You know, our assessment of analytic validity is laboratory by 

laboratory where we are looking at the areas you described and the 

laboratory director’s documentation, that they are following a protocol to detect the appropriate analyte. 

And you highlighted a great example, genetic testing. It is not 

assessing whether different genetic testing kits or combination of 

tests are detecting the disease with the same clinical validity and 

rigor. So you could in fact in the current framework, without premarket assessment of clinical validity, have different tests giving 

different answers to clinicians that could drive treatment that is inVerDate Mar 15 2010 12:10 Aug 03, 2016 Jkt 037690 PO 00000 Frm 00044 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X100DIAGNOSTICSSCANS080216\114X100DIAGNOSTICSPEND
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appropriate, which is why we think the assessment of premarket 

clinical validity in this area is critical and important. 

Mrs. CAPPS. So that leads me to focus now with you, Dr. Shuren. 

Many have argued that there is no need for greater FDA oversight 

of lab-developed tests, as we have not had the same types of problems with LDTs as we have had with drugs such as the outbreak 

of adverse events associated with use of contaminated heparin, for 

example, or adverse events associated with contaminated compounded drugs. They assert that if there are greater health risks 

associated with LDTs, we would have heard about them. 

I am not sure you agree, but it is clear to me from the report 

that FDA released yesterday that lab-developed tests do present 

real risks to patients. Can you please explain whether or not you 

agree with this criticism that came out? Would healthcare providers and patients necessarily know if tests were not giving good 

advice for clinical decisions? 

Dr. SHUREN. I don’t agree with that criticism. And doctors and 

patients would not know who made the device and whether it is 

one that was approved by FDA or it was one that was not approved 

by FDA. Quite frankly, the reason you don’t see as many problems, 

you don’t have the systems in place to identify them. So, for example, for IVDs we regulate, in 2014 we had over 300 recalls. It is 

not unusual. 

Things change, problems arise, but you need the systems to identify the problems and to fix them. And we have some labs who 

have submitted their tests to us, and we have approved or cleared 

some LDTs. And when they put the systems in place, these started 

to identify problems. One of them has already had eight recalls, but 

they only found the problems because they put in the systems that 

they should have in place. 

Mrs. CAPPS. Well, now, how can patients—I am just about out of 

time, but how can patients, providers, and payers be assured that 

the tests they are paying for are providing real value and enhancing the care of patients? 

Dr. SHUREN. Well, that is why we would like to have a uniform, 

consistent approach to diagnostic tests, regardless of who makes 

them. That information will be made available to the public so they 

know what tests have been approved. There is information about 

what those tests are for. The makers have to put out information 

that explains its performance characteristics, its intended use, how 

to use it properly, and all that will provide necessary information 

to doctors and patients so they can use those tests appropriately. 

Mrs. CAPPS. Thank you. 

Dr. SHUREN. Right now, they can’t. 

Mrs. CAPPS. OK. It sounds like we need a follow-up. I yield back. 

Mr. PITTS. The Chair thanks the gentlelady and now recognizes 

the chair emeritus of the full committee, Mr. Barton, 5 minutes for 

questions. 

Mr. BARTON. Thank you, Mr. Chairman. I want to thank both 

our witnesses for attending today. I appreciate the subcommittee 

chairman, the full committee chairman issuing the proposal as a 

discussion draft, which to me means that their minds are still open 

and that we can make some changes and things of this sort. 

42 

I am one of those skeptics that Mrs. Capps just talked about. I 

am not sure that we need to get more Federal regulation. I don’t 

necessarily think more Federal regulation is going to give us a 

safer, more efficacious result. 

So I guess my first question to either of you gentlemen would be 

what is the real problem? I mean why in the world would a laboratory develop a test that wasn’t safe and accurate? My office is not 

being overrun with phone calls or emails from doctors, patients, 

hospitals, advocacy groups that there is some terrible laboratory diagnostic test out in the marketplace. 

Dr. SHUREN. But those tests are out on the marketplace. So, for 

example, a test was developed for something called KIV 6. It was 

supposed to predict the risk of heart disease and response to statin 

treatment. And the lab came out with it, promoted it, said they had 

studies, but then subsequently good studies were performed and in 

fact found that there was no association between KIV 6 and those 

conditions. And by the time it came out, though, over 150,000 people had the tests performed. We estimated the cost to our 

healthcare system was over $2 billion. That is not money we can 

afford to waste on bad testing. 

Mr. BARTON. And what happened—— 

Dr. SHUREN. So what happened—— 

Mr. BARTON. I assume that test was taken off the market and 

without FDA having to do anything. 

Dr. SHUREN. It remained on the market and there was continued 

use for a while and then use started to dip down. But is that really 

the system we want, that we have bad tests, people can get hurt 

by it, and then afterwards if you find the problem and you get on 

top of it, then something happens to the test? The whole point of 

premarket review is and why we do that for the other tests—— 

Mr. BARTON. You are going to guarantee if we would let your 

agency review all these diagnostic tests, the laboratory tests, that 

something like that will never happen again, that you all are perfect and all-knowing and you are going to do it in a cost-effective 

way and it will be peace and light from now until Judgment Day? 

Dr. SHUREN. I will not promise you perfection, and I will leave 

it to God to decide if there will be peace on Earth, but—— 

Mr. BARTON. Well, I am glad to hear somebody use—— 

Dr. SHUREN. But that said, we have—— 

Mr. BARTON [continuing]. The Divinity’s name in a positive way. 

That is—— 

Dr. SHUREN. Yes, well, they can fire me. 

Mr. BARTON. That is a good thing. 

Dr. SHUREN. But we have almost 40 years of experience of regulating in vitro diagnostic tests and assuring that those tests are accurate, reliable, and clinically—— 

Mr. BARTON. I mean, granting your point at least partially, 

wouldn’t it be better to give FDA or some State regulatory agency—it doesn’t necessarily have to be Federal—some sort of a penalty assessment that we can immediately put a stop if there is a 

bad test? Wouldn’t that be a better use of your agency’s resources? 

So to use your example, if that were to happen again, boom, we 

catch it, we stop it, we hit them with a big penalty and get that 

test off the market. I am not being a horse’s rear on this, but, you 

43 

know, if it is not broken, don’t fix it, and it looks to me like we 

are just looking for ways to give the CMS and the FDA more authority. And it is obvious that Chairman Pitts and Chairman 

Upton and I assume Mr. Pallone and Mr. Green are concerned, too. 

But more regulation is not always the best answer. 

I guess my last question would be under the current system what 

role if any do the States play in looking at these tests? 

Dr. SHUREN. So there are States—I can let Dr. Conway talk 

about it in terms of States that are involved in accreditation of laboratories, but they are not involved in premarket review for those 

tests with certain exceptions. New York State does do a review of 

tests. And quite frankly, under the proposal we have, we have the 

opportunity to leverage third parties. If New York State is meeting 

appropriate standards, we could leverage some of the work that 

they are doing. 

But I will tell you the problems are more prevalent than people 

want to recognize. You know, one of the medical centers at the University of Texas was concerned about this—— 

Mr. BARTON. I went to A&M so that doesn’t scare me. 

Dr. SHUREN. No, no, no—well—but I will tell you what they were 

finding is—— 

Mr. BARTON. I am going to hear it whether I want to or not. 

Dr. SHUREN. That is right. Thank you for that. But there were 

inconsistencies in what they were seeing reported by labs for the 

same kind of tests, so what they did is they took results from 105 

of their cancer patients and they had results from one laboratory, 

they sent it to a second laboratory, and of the 32 gene variants, 

they found 50 percent disagreement, 50 percent. And so they even 

concluded that this suggests physician care would differ based on 

different interpretations of different companies. And this is not the 

only report out there, other ones reporting 27 percent finding of incorrect or inaccurate results. This is not uncommon. This goes on. 

It is fixable, and it shouldn’t be fixed after the fact. Why should 

our people get hurt, and only when that happens—and if we can 

find it because we don’t have the systems to do that—do we take 

action. Is that really the kind of health care we want to provide? 

Do we want to spend money on unnecessary care or do we want 

to spend it on innovation and assuring those tests work. 

Mr. BARTON. Well, I am with you on the innovation part. 

Mr. Chairman, you know, the other subcommittee’s got the FCC 

commissioners downstairs, so I am not going to be able to stay, but 

I appreciate you holding this hearing and thank you for the courtesy of the time. 

Mr. PITTS. The Chair thanks the gentleman and now recognizes 

the ranking member of the full committee, Mr. Pallone, 5 minutes 

for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

I wanted to ask Dr. Shuren. As you know, various stakeholders 

have been circulating legislative proposals regarding the regulation 

of lab-developed tests. Among these various legislative proposals, 

there seems to be a great deal of variance around moderate-risk 

tests. Some proposals have suggested that no premarket review is 

necessary for moderate-risk tests, and one proposal would require 

44 

premarket review of moderate-risk tests but would allow such tests 

to be deemed approved if FDA did not act in a specified time frame. 

So I wanted to ask you a couple questions about this. In your testimony you noted an example of a test that is moderate risk would 

blood glucose strips used by people with diabetes and tests to help 

doctors diagnose heart failure. Could you discuss what FDA considers to be moderate risk and provide some examples of tests that 

would be considered moderate risk? 

Dr. SHUREN. So other moderate-risk tests would be for diagnosing cystic fibrosis, herpes, heart failure are all moderate-risk 

tests—— 

Mr. PALLONE. OK. 

Dr. SHUREN [continuing]. That we currently regulate. 

Mr. PALLONE. Does the FDA believe that premarket review of 

moderate-risk tests that there should be, and if so, can you describe when you believe that premarket review of a moderate-risk 

test would be necessary? 

Dr. SHUREN. So we do believe that most moderate-risk tests 

would be subject to premarket review. That is what we do now, but 

we do find that there are certain circumstances where we can put 

other mitigations in place that are good enough and you don’t need 

premarket review. We just did that a little while back for next-generation sequencing platforms, when they are just making tool 

claims. We just did that for autosomal recessive carrier screening 

tests. And that is a natural course of action. As the science develops, technology evolves, we can actually change risk classification 

or what a test will have to do to come on the market. That is hallmarks of a risk-based approach. 

We are also very concerned about this deemed-approved approach. It essentially says if we don’t make it decision in time, it 

is approved. So a test goes on the market that may be inaccurate 

simply because we didn’t have enough time to finish up the review 

or, alternatively, we will not approve it to not let it go on the market. And yet if we had the time to work with the lab, we might get 

a good test on the market. Either way, bad tests on the market, 

good tests not going on a market, the loser is patients. 

Mr. PALLONE. OK. I think you answered my next question, which 

would be, you know, the deemed approval if FDA does not act. But 

let me say, can you comment on whether or not—yes, I think you 

already talked about the deemed approved. So let me go to another 

question, Dr. Shuren. 

I understand that once the test is approved or cleared by FDA 

and enters the market, laboratories frequently modify the kits either to expand uses or to make improvements to the way the test 

is performed. And some stakeholders in the lab community have 

even suggested that manufacturers rely on laboratories to modify 

tests in order to expand the uses because it is too costly or burdensome to have a test approved for every use. So do you believe that 

modifications to LDTs should be subject to premarket requirements, and if so, what types of modifications would FDA want to 

look at before they are put in place? 

Dr. SHUREN. So we think most changes that are made would not 

be subject to FDA review, and that is actually what occurs now for 

other IVDs. We would review those changes when there is a new 

45 

intended use because it truly is a new test. Even CLIA have used 

that as a new test. Or if there is a big enough change that when 

a test is approved would determine what its performance specifications are, if now you make a change and it goes outside the performance specifications, we would review that as well. 

Mr. PALLONE. OK. 

Dr. SHUREN. But it is those kinds of changes. 

Mr. PALLONE. Let me go back. There was other thing that I could 

have asked you about, these tests are deemed approved if FDA 

didn’t act in a certain time frame. Can you explain whether or not 

you believe patients, physicians, or payers would know which tests 

were affirmatively cleared or approved by FDA versus tests that 

were deemed to be approved? Is there any way that they would 

know that? 

Dr. SHUREN. No. I mean if the test is approved, the test is approved. 

Mr. PALLONE. So that is one of the dangers if you will. In other 

words, you said before that you would be concerned that you might 

approve something that shouldn’t be or not approve something that 

could be. But the secondary problem is that the user is not going 

to know. 

Dr. SHUREN. That is exactly right. 

Mr. PALLONE. All right. Thanks a lot. 

Mr. GUTHRIE [presiding]. Thank you. And the gentleman yields 

back. I now recognize myself for 5 minutes for questions. 

Dr. Shuren and Conway, what does premarket review mean in 

the context of lab-developed tests, or LDTs? And how important is 

it and who should be responsible for such reviews? 

Dr. SHUREN. So our premarket review is to determine if the tests 

are analytically valid, clinically valid, and they are safe for use 

under their conditions for use. And it is important to conduct those 

reviews for moderate- and high-risk tests to make sure they work 

because doctors and patients rely on those tests to make well-informed healthcare decisions. If they get inaccurate results, they 

could make the wrong decisions and people get hurt as a result. 

Mr. GUTHRIE. Thank you. Dr. Conway? 

Dr. CONWAY. I agree with Dr. Shuren. And from the CLIA/CMS 

perspective, you know, we are really focused on laboratory-by-laboratory post-market review of those laboratory protocols, equipment, training of personnel, et cetera. 

Mr. GUTHRIE. OK. Thank you. And I have heard that the same 

type of diagnostic test that is commonly available as both an LDT 

and a manufacturer kit that can be purchased by a lab, and tests 

for melanoma are one example. In other words, I could go to hospital A where they have a lab that developed their own test or, by 

chance, I could go to hospital B, whose lab purchased a test from 

a manufacturer. Can either of you walk me through this scenario 

from a regulatory perspective? In the case of hospital A, is it true 

that neither FDA nor CMS will have reviewed that test for clinical 

validity? 

Dr. SHUREN. That is true. The test across the street would have 

been reviewed, and therefore, doctors and patients have the confidence to be able to rely on it, and you don’t know in the case of 

the other one that has been offered. 

46 

Mr. GUTHRIE. OK. Same—— 

Dr. CONWAY. Yes, same. And CMS, once again, would not review 

clinical validity as part of the CLIA process. 

Mr. GUTHRIE. OK. Doing the premarket review of these types of 

tests, could each of you describe the general education and professional background and expertise of your reviewers? 

Dr. SHUREN. So our review, particularly for more complex tests, 

tends to be performed by a team of experts. They may include physicians, Ph.D. scientists, and statisticians that do a deep dive into 

the scientific data. We review the science to see if in fact and not 

only that test works but what it is claiming to do matches up with 

the science. 

Mr. GUTHRIE. Thank you. Dr. Conway? 

Dr. CONWAY. Our CLIA team does not include any medical officers or other personnel trained in detailed biostatistics or Ph.D.- 

level training. Our CLIA team is really focused on, as I mentioned, 

laboratory assessment on an accreditation and quality and survey 

and certification framework in a post-market manner laboratory by 

laboratory. 

Mr. GUTHRIE. Thanks. And, Dr. Shuren, you previously testified 

about challenges you face in hiring and retaining sufficient medical 

expertise. How would your ability to do so be impacted if CMS 

were required to have the same types of expertise regarding test 

design and development? 

Dr. SHUREN. Well, first off, I want to thank the committee for 

trying to take actions in 21st Century Cures to help us to better 

be able to attract and retain high quality talent. And that is where 

the answer lies. 

Mr. GUTHRIE. So the competition if CMS is doing the same would 

be—— 

Dr. SHUREN. Well, it makes no sense for competition, so all we 

are going to do is create a duplicative system in another agency. 

I mean it is interesting that people have raised concern about do 

not have duplicative regulatory frameworks in place, and yet some 

of the proposals we have seen now to put this under CLIA would 

do exactly that. It would create all this duplication the right now, 

as you have heard from both of us, doesn’t exist. 

Mr. GUTHRIE. All right. Thank you. And I yield back the balance 

of my time. 

And I now recognize Ms. Castor from Florida. 

Ms. CASTOR. Thank you, Mr. Chairman. And thank you both for 

being here today. 

As we continue to develop a greater understanding of the genetics of individuals who have a wide variety of diseases and conditions, we are moving away from one-size-fits-all medicine to more 

targeted and effective prevention strategies and treatments and 

even cures. This is known as personalized medicine, and I believe 

it is fundamental to the vision of 21st Century Cures and holds 

great promise. 

This vision, though, will in large part be dependent upon accurate genetic tests, so it is imperative that these tests are scientifically credible. Dr. Shuren, can you provide some examples of the 

types of genetic tests that are being developed to help deliver perVerDate Mar 15 2010 12:10 Aug 03, 2016 Jkt 037690 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X100DIAGNOSTICSSCANS080216\114X100DIAGNOSTICSPEND
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sonalized treatment? And describe in greater detail the role that 

these tests play in precision medicine. 

Dr. SHUREN. So increasingly, we are seeing genetic tests being 

developed to help identify what the appropriate treatment may be 

for patients who have various conditions, including cancer. And it 

is critically important that those tests work, because if not, people 

are not getting the right treatment or they are not getting treatment when in fact they should get treatment. 

I will say that as we approach this, though, Government can be 

innovative. Increasingly, we are seeing next-generation sequencing 

tests being used, and last December, we put out a proposal for a 

new approach on next-generation sequencing that, rather than your 

standard model of maybe doing a clinical study is to leverage data 

in existing curated databases, which can allow for the clinical community to crowd-source the evidence, and as the science ultimately 

evolves to where it needs to be to be able to make claims about the 

use of that test. That way, the regulatory framework can stay stepin-step with the evolution of the science. 

In fact, we just held a two-day public meeting last week on this. 

There is a lot of support for moving forward with this approach. We 

have even relied on those curated databases to approve a test for 

cystic fibrosis. 

So that is where we need to focus our attention, and that is why 

we want the lab community at the table with us. Let’s focus on the 

science. That is what we need to do. We have the regulatory tools. 

It is the science we have got to work together on. And we can do 

it if people are willing to work with us. 

Ms. CASTOR. Yes. And during our 21st Century Cures hearings 

and briefings, there was a lot of talk about data-sharing. What is 

going on—because we can’t wait for Congress to act, frankly. What 

is going on with FDA and NIH and a lot of those research institutions across the country in being able to look at that data, share 

it, so we can develop the cures and treatments of the future? 

Dr. SHUREN. Yes. So NIH has its own database of genetic 

variants. They do an assessment. We have other databases out 

there. We are now trying to work with these various groups on 

what the appropriate standards should be for the quality check for 

the curation and what should be the standards for clinical validity 

when you are evaluating that science. 

Also, we at the FDA have been developing a platform called precision FDA that would allow these test developers to essentially either share their genetic data to compare or providing analytical 

tools so they can test-drive some of these next-generation sequencing technologies to see if they are accurately sequencing the genome. We think this is a great role, if you will, to provide these 

common goods to all developers. 

Ms. CASTOR. Great. I do, too. Thank you. And I yield back my 

time. 

Mr. GUTHRIE. Thank you very much. The gentleman from Illinois, Mr. Shimkus, is recognized for 5 minutes. 

Mr. SHIMKUS. Thank you, Mr. Chairman. And welcome. 

Actually, I appreciate the comments from my colleague from 

Florida. That is kind of where I was just heading to a little bit, too, 

with the personalized medicine and the genetic testing and really 

48 

being accurate on that test so then you can, as we talked about in 

the other piece of legislation, target based upon the genetic code or 

the individual patient. That is very exciting. 

And the other thing I think we have followed through the hearings and the 21st Century Cures is that then you just don’t go 

down the route of prescribing remedial health action to someone 

without really full information, so the high cost of health care because you try this, didn’t work, try this, didn’t work, now you are 

trying this, and you can get more specific information. So it is very 

exciting times. And I think people were going around the same 

issues. 

But I wanted to ask this, and it is probably something I should 

know if I would have more thoroughly read my briefings, but when 

we talk about risk—basic, moderate, or high—so we are really focusing on moderate and high risk of the tests. What is the risk 

component? Is the risk component the risk of conducting it, the risk 

of not having accurate information, or the risk to the patient who 

hopes to get good information from a test because of the healthcare 

environment they presently find themselves in? So can you both 

talk on how do we define risk? 

Dr. SHUREN. Yes. So the key consideration is the risk to the patient if they are getting an inaccurate result, they are getting a 

wrong result, and that is within the context of what would otherwise happen to that patient in clinical care. That is the way we 

look at it. 

Mr. SHIMKUS. So when you use the example of heart, you put 

that in a moderate—when you were giving the examples of—and 

I was kind of surprised. I mean, heart disease or heart issues, I 

think people would find it pretty risky if you have got heart disease, a higher risk than just in the moderate category. So there is 

some subjectivity to this or—— 

Dr. SHUREN. Well, so when we look at it, you put it within the 

clinical context. So in the case of heart failure, when you are making, you know, a diagnosis, there are other things that the clinician 

takes into account in making that determination. That is a little 

bit different, though, when I am dealing with something, let’s say, 

like HIV where not only am I dealing with a high-risk condition, 

right, the risk to the patient is huge, secondly, I don’t have another 

great means of truly determining is that HIV. And then there is 

also the risk of if I am wrong about this and that person goes out 

and doesn’t know they have HIV, they may engage in activities 

that they will spread the disease. So we are really looking at it in 

the practical context of what in fact happens to the patient, not 

just simply the condition itself. 

Mr. SHIMKUS. Right. And I think this is a tough area for conservative Republicans who think Government is too big, costs too much, 

but there is obviously a position of we want to make sure that people are advertising and using tests, that they are given some stamp 

of approval, that they meet the requirements and the desires of 

what they are. 

So, Dr. Conway, real quick, you admit that the volume and complexity of these tests have kind of grown, I don’t know, I would say 

exponentially almost. Would you agree with that? 

49 

Dr. CONWAY. Yes. We don’t have exact numbers for some of the 

reasons described, but it seems exponential. 

Mr. SHIMKUS. But you haven’t asked for new authorities because 

of this growth, have you? 

Dr. CONWAY. So CMS has not put forward additional requests for 

statutory authority. As I mentioned, we think FDA can play a critical role in the premarket review, and we can play a critical role 

laboratory by laboratory, post-market. 

Mr. SHIMKUS. Yes, in your area do you require an individual review of the area that you have been involved with? Is there an 

independent review process of decisions that you are making, you 

know, in the CLIA process? 

Dr. CONWAY. Let me try to answer that. So I think we have a 

central office that has oversight of State surveyors, and therefore, 

oversight of the processes of those State surveyors. We also oversee 

accrediting organizations, of which there are seven. They have to 

meet or exceed CLIA standards, and we review that, including if 

any—— 

Mr. SHIMKUS. But you are almost evaluating the organizations. 

The organizations aren’t evaluating the independent decisions? 

Dr. CONWAY. We have bidirectional communication both with the 

States and their accrediting organizations like in any of our accrediting organizations, including at times in various programs accrediting organizations identify regulations or standards that need updating. 

Mr. SHIMKUS. Great. Thank you very much. I yield back my time. 

Mr. GUTHRIE. I thank the gentleman. The time is expired. 

And I recognize Dr. Schrader from Oregon for 5 minutes for 

questions. 

Mr. SCHRADER. Thank you, Mr. Chairman. And I would like to 

thank Dr. Shuren and Dr. Conway for being here. Interesting topic. 

I would hope that the chair or vice chair and ranking member 

would hopefully have us have an opportunity to talk to the stakeholders, including the physician groups, just to get a balanced perspective here. This is pretty darn important if we are going to go 

down this road, and I think the tender of the questions so far indicate that. 

And I appreciate the fact both of you testified in total agreement 

in pretty clear terms about how you guys have two different jobs 

in the different agencies. It is tough from a practitioner’s standpoint, being part of the medical community, to really understand 

why that has to be. I understand it is right now, but I am not sure 

why it has to be. It seems odd to me that the Center for Medicare 

Services—medical services would not have some sort of health regulatory role or clinical analyzation capability. 

And it seems to me both of you are going to have to staff up, 

well, particularly FDA if you take on this new role of premarket 

approval. There is going to be a huge staffing increase. Why would 

that not also be possible for the folks in CLIA or somewhere in 

CMS to do the same thing? I ask both of you that question. 

Dr. SHUREN. So we already have existing staff who do exactly 

these kinds of reviews, and we have years of experience on it. We 

have training programs for our people. And in terms of additional 

resources, one of the reasons that we put in place a phased-in apVerDate Mar 15 2010 12:10 Aug 03, 2016 Jkt 037690 PO 00000 Frm 00053 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X100DIAGNOSTICSSCANS080216\114X100DIAGNOSTICSPEND
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proach would be also for tests that are out there, one, not disrupt 

the market; two, that we could try to accommodate what resources 

we have. But in addition, if we need additional resources, we have 

a user-fee program under which we work with the regulated community about appropriate funding for services that we then provide 

back like performance and premarket review. And that program, as 

you know, has been in place for a number of years. 

Mr. SCHRADER. So minimal staffing increase is what you are suggesting? 

Dr. SHUREN. It depends on the ultimate framework that goes into 

place as to what that workload would look like. 

Mr. SCHRADER. All right. Mr. Conway, if you can. 

Dr. CONWAY. On the CMS side, as I mentioned in the central office we have approximately 25 people in total overseeing CLIA. 

They are trained for their job, which they do well, which is oversight of laboratories, laboratory by laboratory. There are no medical officers, there are no Ph.D.’s, biostatisticians because we do not 

do premarket review. 

Mr. SCHRADER. I just get concerned still—sorry—because both 

your testimonies talk about accuracy, both of you. You both talk 

about reliability. And that sounds like overlap to me. So I am just 

concerned that we don’t go down that road. Question on peer-review. I mean a lot of treatments and diagnoses are peer-reviewed 

in the literature and stuff. Has that occurred at all with laboratory 

tests? Is there any literature reviewing the efficacy of different laboratory tests? 

Dr. SHUREN. In our review of tests we do look at published literature, and in some cases we have relied completely on published 

literature for certain tests like hemoglobin A1c for diabetes. 

This issue about accuracy, our look at it, though, for analytical 

validity is complementary but it is different. We truly look at is the 

test itself and what it measures, is it in fact accurate? CMS will 

look at is that test performed properly to get a result. 

Mr. SCHRADER. That is correct. So I guess my underlying concern 

as a medical professional listening to the testimony is that the consumer, as well as the physician or veterinarian, is not misled by 

having premarket review. There is going to be some certainty that 

that test is 100 percent appropriate for them in their situation. 

The reason I raised the question about the peer review, I mean, 

generally, the test from my standpoint is a secondary adjunct to 

helping establish the diagnosis. You got a lot on clinical sides, you 

got a lot on knowing your patient, got a lot to, you know, based on 

the environment they are living in. There are false positives all the 

time in every single test, false negatives in virtually every single 

test, whether it is a genetic test or, you know, a simple blood test 

for goodness sakes. I just don’t want the consumer to be misled 

that by having FDA premarket approval, that that test is going to 

be 100 percent. I think that is a mistake. 

At the end of the day I think it is up to the medical community, 

the physician to put that one small piece of the puzzle into the, you 

know, whole diagnostic scheme and come up with whether or not 

that is actually going to be a valid use of their patient. 

I am just very concerned the tone here is that we are going to 

put certainty into the art of medicine when there is not that much 

51 

certainty, and the patient will be misled and frankly lead to greater lawsuits and customers frankly not understanding what medicine is really all about. 

Dr. SHUREN. And so the accuracy of that test will also depend on 

what the use of the test is for. You know, when you deal with 

riskier conditions or where there are some tests you truly rely on 

the result of that test. Companion diagnostics, for example, it is the 

result of that test that will be telling you should they get Zelboraf, 

you know, for melanoma. And in those cases you want to have a 

higher accuracy. 

You are right, it is not 100 percent, but also what we assure you 

is that that information is made available to the practitioner like 

you, and you know that when you get that number for how accurate it is, the result, it is correct. It is the—— 

Mr. SCHRADER. Well, laboratories have different—laboratory information from one lab to the other is going to be different. I can 

send the exact same blood sample in to a different laboratory. I can 

send the genetic code in. You testified a moment ago you are going 

to get different information back. So the idea that it is going to be 

dispositive, I would respectfully disagree. And I yield my time. 

Mr. GUTHRIE. Thank you. The gentleman’s time is expired. 

I now recognize Dr. Burgess of Texas for 5 minutes. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Before I start my time, could I asking for a unanimous consent 

request? 

Mr. GUTHRIE. The gentleman is recognized. 

Mr. BURGESS. Ask unanimous consent to enter the statement of 

the Association for Molecular Pathology into the record. And then 

a further unanimous consent request for a point of personal privilege, Mr. Chairman. 

For the past 7 years I have been joined at these committee hearings by Mr. Paluskiewicz, whose last name is so difficult to pronounce we all know him by J.P. And if I ever seem adequately prepared for these hearings, it is only because I have had J.P. advising 

me before we come into the hearing room. And so it is with great 

sadness that I announce that J.P. will be leaving my employment, 

but he will be joining the committee staff, so he will be here for 

all to participate and the wondrous things that he has to offer to 

any committee hearing. 

Thank you, Mr. Chairman. Now recognize for questions. 

Dr. Conway, so if Dr. Shuren puts his guidance out in January, 

are you no longer necessary? 

Dr. CONWAY. No, sir, and let me explain why. I think there will 

still be a role for CLIA to assess, and this is a critically important 

role, that laboratories have the proper equipment, training, protocols, and quality assurance procedures in place, and that laboratory-by-laboratory certification, which a few people have talked 

about, is a critical role for CLIA. 

Mr. BURGESS. But, you know, we have heard several times the 

FDA is under-resourced, so why shouldn’t the resources that are 

going to CMS just simply go to the FDA? 

Dr. CONWAY. So I will speak for CMS. You know, I think in the 

CLIA oversight framework we are efficiently using both central office resources and relying on States, which was a question earlier, 

52 

and their State surveyors, obviously a user-fee funded program 

based on user fees based on moderate, high complexity, et cetera, 

and volume. And then we also importantly have nonprofit accrediting organizations that are not Government organizations, that 

we—seven of them—approve that they meet or exceed CLIA standards. We are using people outside of the Federal Government as 

well to perform these important functions. 

Mr. BURGESS. Dr. Shuren, this question has been posed to you 

several times in this subcommittee or oversight subcommittees 

about what is the problem that we are trying to solve? And last 

night at 7:00 p.m. you put out a report that detailed 20 times 

where perhaps there were problems with laboratory-developed 

tests, is that correct? 

Dr. SHUREN. Yes. 

Mr. BURGESS. And I am sure you would make the further statement that there are more than that, but we have also seen in testimony that what is the total universe of laboratory-developed tests? 

It is in excess of 11,000, is that correct? 

Dr. SHUREN. It is above 11,000. 

Mr. BURGESS. So the rate at which you have detected problems 

would be, if my math is correct, .18 percent, which most things in 

medicine are hardly that reliable. Is that an unfair statement? 

Dr. SHUREN. Yes. Reporting systems—first of all, there is no reporting system on LDTs. You are not monitoring for problems. And 

so you can’t say what the rate is, quite frankly. 

Mr. BURGESS. It took you 3 years to provide us with 20. When 

I asked you in hearings, when we were doing the FDA reauthorization, what is the problem we are trying to solve? So today, now, I 

have your report, 20 problems that we are trying to solve, and we 

have got a universe in excess of 11,000 tests. 

So let me just ask you this, since you think the risk is there from 

laboratory-developed tests, is there an FDA-approved kit that has 

ever had a failure? 

Dr. SHUREN. Yes. And the point is the reason we can identify 

when there are problems and we can deal with it is because we 

have the systems in place and the maker of the test has implemented systems internally to identify those problems. That is critical. And the work that we are doing doesn’t occur right now in 

CMS. It is not duplicative, and they don’t go away. 

Remember, if you make a test, if you are a conventional manufacturer, that lab is going to get your test. They still have to perform that test properly, and that is what CMS is overseeing, are 

the laboratory operations conducted properly. 

Mr. BURGESS. My time is limited. So do you envision any lack of 

access to testing because of the changes that you are proposing in 

the guidance or the committee is proposing in their legislation? 

Dr. SHUREN. So we have tried to—a proposal was put in place 

so that we would not disrupt the marketplace. Our goal here is to 

try to assure we do have innovation. We think LDTs are important 

in health care. There is innovation, but—— 

Mr. BURGESS. I appreciate the recommendation—— 

Dr. SHUREN [continuing]. There is no value to patients if the 

tests in fact don’t work. And one of the problems is because we 

haven’t regulated, there has been a disincentive for innovation by 

53 

conventional manufacturers. And we have heard from them, particularly the smaller companies are saying they are disadvantaged 

because they make a test and they go through and they have to 

demonstrate their test works. And then you can have a lab make 

the same kind of test go out the door—— 

Mr. BURGESS. I am going to have to interrupt you because my 

time is limited. 

Just as far as the labs themselves, who do you expect to be more 

greatly impacted, large labs and large hospitals or smaller rural 

labs? Is there likely to be a difference in the impact? It is a yesor-no question. 

Dr. SHUREN. The answer is you should regardless be developing 

the science that your test is validated, whether we review it or not. 

Mr. BURGESS. If you don’t know whether the answer is yes or no, 

why wouldn’t we want to see an economic impact evaluation such 

as normally would be required in rulemaking but is not required 

in guidance? 

Dr. SHUREN. Well, just to clarify again, whether we were overseeing them or not, a lab shouldn’t be putting any test on the market that they haven’t gotten the data to validate. What we are saying is you should have the data and we would look at it before the 

test went on the market to make sure that that test in fact worked. 

Mr. BURGESS. And to the question—— 

Dr. SHUREN. The tests that wouldn’t go on the market are the 

ones that in fact don’t work. 

Mr. BURGESS. And to the question of an economic impact statement, as would be required under normal rulemaking processes, 

why shouldn’t the committee or the Congress expect that? 

Dr. SHUREN. We are not under rulemaking because we are not 

imposing new requirements. These requirements already exist 

under the law. As a matter of policy, we have not actively enforced 

them. And in places where we put an enforcement discretion policy, 

we have withdrawn it. We have done that through guidance. It has 

been the practice all along. 

I would say in terms of economic analysis, too, we now have seen 

the lab community has come forward to say LDTs need to demonstrate analytical and clinical validity. Moderate- and high-risk 

LDTs need to be subject to premarket review. So those pieces, even 

the lab community has now said, you know what, that kind of a 

framework needs to be in place. 

Mr. GUTHRIE. The gentleman’s time is expired. Would you again, 

Dr. Burgess, make—you had one unanimous consent request that 

we did not act on, then you went to a point of personal privilege. 

Can you make that once again before we move on? 

Mr. BURGESS. Yes. It was to add to the record the statement 

from the Association of Molecular Pathology for the record. 

Mr. GUTHRIE. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. GUTHRIE. Thank you. 

Mr. BURGESS. Thank you. 

Mr. GUTHRIE. The Chair now recognizes Mr. Sarbanes from 

Maryland for 5 minutes for questions. 

Mr. SARBANES. Thank you, Mr. Chairman. I thank the two witnesses for being here. 

54 

This is obviously a very important discussion, and I always try 

to look at these conversations through the eyes of sort of my constituents, people out there, and I have got to believe that if some 

of them are paying attention to this hearing, they would be 

scratching their head, the typical patient out there, and saying, you 

mean these kinds of protections and reviews and guidance and so 

forth are not already in place? 

And I understand that, you know, you start out in a different 

time period, and you are now trying to sort of update the framework that exists to protect patients out there, and I think the average person would think that this is a very reasonable undertaking 

on your part. So there is going to have to be some heightened degree of oversight and assurance in this arena. 

You have probably touched on all this before I came, but could 

you just take maybe two or three or four of the main categories of 

kind of constituencies out there and give me a shorthand on their 

perspective? What are physicians saying about this conversation? 

What are patient advocate groups saying? I think I can probably 

guess. You have alluded to the industry, the lab industry itself, but 

can you just—and in particular, I guess the physician perspective 

on it would be helpful to me, but if you can kind of shorthand those 

different lenses on this discussion. 

Dr. SHUREN. We have heard mixed perspectives from the physician community. So oncologists have come out to say, yes, you need 

oversight, you need FDA oversight. Pathologists have felt that, no, 

we do not. FDA shouldn’t be or should have little role in oversight 

of LDTs. The patient groups have been supportive of FDA. The consumer groups, payers have been—the medical device industry has 

been, the laboratory community has been split. Some of the labs 

have been working and promoting a proposal with FDA oversight, 

and the others have been proposing a system under CLIA. 

Mr. SARBANES. The payers, that is interesting. Can you expand 

a little bit on that? Is that because they are seeing a lot of costs 

associated with faulty test results in the use of those? 

Dr. CONWAY. Maybe I will start since I am a large payer. It is 

a challenge in the payer aspect, so including in Medicare and similar and private payers. If the tests haven’t gone through that FDA 

review, then we have a system of local contract medical directors 

in our national office also, you know, small numbers of people trying to review thousands of tests that either are identified to us or 

we identify that we need to assess reasonable and necessary for 

coverage. If there were an FDA review, you could potentially take 

a whole set of those that have been through FDA review and have 

those be covered and focus on the ones that are leftover. So this 

is an issue there. 

If you don’t mind, on the practicing physician point, I am a practicing physician. I train residents and medical students on weekends as well. You know, you want an assurance as a physician that 

the test is clinically valid and that the report that says the patient 

has cancer or genetic disease X is correct. And the patient wants 

that assurance as well. 

Mr. SARBANES. Right. 

Mr. GUTHRIE. Thank you. And the gentleman yields back his 

time. 

55 

Mr. Lance of New Jersey is recognized for 5 minutes for questions. 

Mr. LANCE. Thank you very much, Mr. Chairman. Good morning 

to you, gentlemen. 

Dr. Conway, it is my understanding that it is the Division of 

Laboratory Services within the Survey and Certification Group 

within the Center for Clinical Standards and Quality at CMS that 

has responsibility for administering the program. How many staff 

within the division are responsible for inspecting labs and reviewing the tests they performed? 

Dr. CONWAY. We have approximately 25 central office staff, and 

then we have approximately 110 surveyors across the Nation and 

all the States, so a small number per State. 

Mr. LANCE. We have heard that there are tens of thousands of 

LDTs out there. Do you believe that the division is capable of reviewing all of these LDTs in a timely fashion for clinical validity? 

Dr. CONWAY. No, they are not, either in a timely fashion or with 

the current training of the staff that we have. 

Mr. LANCE. And therefore, do you believe that new innovation 

would be effective, I presume, negatively because of the potential 

backlog? 

Dr. CONWAY. Yes, I would be very concerned about a potential 

backlog and the impact on innovation. 

Mr. LANCE. Dr. Shuren, how would the FDA handle the workload 

and how would these submissions be based in line, on what priority 

if this were to be handled by the FDA? 

Dr. SHUREN. To handle workload, it is one of the reasons we 

have put in a phased-in approach over a number of years, and review would occur—be prioritized based upon risk. What we proposed is we would start reviewing higher-risk devices before we 

would look at—high risk before moving to moderate risk. 

Mr. LANCE. And to the best of your ability, how long do you believe it would take to review an LDT, your best estimate, Doctor? 

Dr. SHUREN. So for the moderate risk LDTs now, the review 

times are—total times are a little over 100 days, thereabouts. 

Mr. LANCE. Thank you. Thank you, Mr. Chairman. I yield back 

the balance of my time. 

Mr. BURGESS. Would the gentleman yield to me? 

Mr. LANCE. I yield to Dr. Burgess. 

Mr. BURGESS. Thank you. 

Mr. GUTHRIE. Dr. Burgess is recognized. 

Mr. BURGESS. On that point, could you state that figure again, 

the moderate-risk LDTs, 100 days? Is that right? 

Dr. SHUREN. No, a little over 100 days. 

Mr. BURGESS. So there are 11,000 and some laboratory-developed 

tests. You said earlier that 50 percent are low risk, so presumably, 

that leaves 50 percent that are in the moderate- or high-risk category, is that correct? 

Dr. SHUREN. Yes, that is correct. 

Mr. BURGESS. So extrapolating out the number of days, assuming 

none of them are high risk, they are all low risk, and that is over 

100 days of evaluation at the FDA, I mean that is a phenomenal 

amount of work that is ahead of you, is it not? 

56 

Dr. SHUREN. That is one of the reasons why we have looked at 

phased-in approach. We have gotten feedback, too, if we should 

consider any changes and take a different approach for some of the 

tests that are currently on the market, which we are doing. And 

we are also having those discussions about funding needs as part 

of user fee discussions, which are going on right now. They get authorized every 5 years. And that has been the natural course of 

business. 

We have those discussions with regulated industry—the laboratory community is that the table—to then talk about if people want 

to see a certain performance, what does that look like. We know 

in some of the proposals people have said for moderate-risk tests 

could that review time be 75 days? We can have a discussion about 

what it would take for review in 75 days. 

Mr. BURGESS. I will say some of the performance metrics that 

were introduced after the last FDA reauthorization in 2012, I don’t 

know that we ever got satisfactory answers back to this subcommittee or the Subcommittee on Oversight as to how the performance was on that, but there is a general unease that the FDA 

is able to perform its function in a timely fashion. During the time 

that we were doing the hearings for the FDA reauthorization, there 

was hardly a week that went by that there was not someone in my 

office with a tale of woe about a drug or device that just seemed 

to take forever in development and that the FDA would sometimes 

change the rules as that drug or device went through the development process. What assurance can we give to the laboratory-developed test community that they won’t encounter similar problems 

with your agency going forward? 

Dr. SHUREN. Well, our review times have been actually improving under MDUFA III. We are meeting our performance goals, as 

we committed to do. So we are seeing things move in the right direction. And I don’t know what is happening to people coming into 

your office now. I have heard from other Members that they don’t 

have the parade of people that were coming in several years ago. 

And you know when I took over the program several years ago, 

I was very upfront with this committee and others that there were 

challenges in the medical device program. We had seen roughly a 

decade of worsening performance, and we committed to turn that 

around. We committed to make changes regardless of what happened with MDUFA, and then MDUFA came along to give us additional resources. And we have continued to see improved performance, and we are going to continue to work on it, as we have been 

doing all along. 

Mr. GUTHRIE. Thank you. 

Mr. BURGESS. I don’t know that I share your enthusiasm. Thank 

you, Mr. Chairman. 

Mr. GUTHRIE. Thank you. The gentleman from New Jersey’s time 

has expired, and recognizing Mr. Cardenas from California for 5 

minutes for questions. 

Mr. CA ́ RDENAS. Thank you very much, Mr. Chairman. 

My first question is to FDA and CMS. Today in your budgeting, 

are you being asked to do more with less? 

Dr. SHUREN. Yes. 

57 

Mr. CA ́ RDENAS. I am not talking about prospectively. I am talking about in the cycle that you are currently in. 

Dr. SHUREN. Yes, and that has been even the cycles before then. 

We are always asked to do more with less. 

Mr. CA ́ RDENAS. OK. 

Dr. CONWAY. Yes. So it is also true for CMS, long history of doing 

more for less. Thank you for the more with less. Thank you for the 

question. I mean, I have managed in the delivery system. I have 

managed in CMS. I have never managed somewhere as hard as 

this. It is ridiculously harder than running a delivery system. And 

the reason is the amount of resources for the job. We are deploying 

lien and other operational techniques to increase our efficiency, 

learning from manufacturing and health systems, and that is working, but this is a major issue. 

Mr. CA ́ RDENAS. OK. Thank you for clarifying that. I don’t think 

the public understands how taxing it is for our agencies to continue 

to do more and more and more and try to protect the public and 

allow the American public to know or feel as though there are protections and the agencies are trying their best to look out for making sure that when they are engaged in something that is a— 

whether it is FDA-approved or it has gone through review of CMS, 

et cetera, that they can feel safe. 

So thank you for continuing to wade through the struggle of 

doing more with less and doing your best to keep up with that. I 

hope that we as the holders of the purse, Congress, will recognize 

that and realize that we are impeding on the safety of our American citizens when we just say no to a reasonable request of resources and we just say do with what you have and do a better job 

and just make it happen, easier said than done. 

And thank you for clarifying that in the environment that you 

have been and that this is probably the—I interpret that what you 

said is this is the most difficult environment for you to do justice 

to your efforts than any other environment you have been in. 

Dr. CONWAY. Yes. And I—— 

Mr. CA ́ RDENAS. And understand you are not coming across to me 

as complaining. 

Dr. CONWAY. No. 

Mr. CA ́ RDENAS. I think it is important that you just be honest 

with us the way you have been. Thank you. 

Dr. CONWAY. Yes. No, do you mind if I—— 

Mr. CA ́ RDENAS. No, go ahead, please. 

Dr. CONWAY. This is the best job I have ever had and the most 

impactful, which is why I have stayed, but the challenge of managing in the CMS environment with the resources we have for the 

duty we have for the American people is by far the hardest job I 

have ever had. And I have led in the private sector, large groups, 

large budgets. It is nowhere close. This is the most challenging job 

I have ever had in my life. 

Mr. CA ́ RDENAS. And again, I thank you for welcoming the challenge. It is too bad that we don’t lessen that challenge by giving 

you the resources for you to be more effective without worrying 

about not being effective in your responsibilities. 

My family just got the news recently that my wife and I are 

going to be grandparents for the first time. And just the other day, 

58 

we were invited to my daughter and my son-in-law’s house, and 

they revealed to us it is going to be a boy. And the reason why they 

found is because my daughter underwent a test that went to a laboratory and the results came back. And one of the things that they 

could tell her—it wasn’t the purpose of the test, but one of the 

things they could tell her is the gender of the fetus. And so it was 

a wonderful moment. 

However, what if the purpose of that test had been inadvertent, 

the results had been inadvertent? I think that is really what the 

focus of today is about. It is about safety of the public. It is about 

accuracy of what is going on out there. It is about whether or not 

they are being effective. And unfortunately, for those people who 

want less Government or no Government, there needs to be oversight from somewhere. I personally prefer that Government be involved in that oversight instead of just turning it completely over 

to private industries, which happens in some cases. 

But my question to you is, going forward, how do we as a country 

make sure that between CMS, between FDA, what your role can 

be in making sure that these critical tests, these laboratories are 

being accurate with the information to the patient, to the actual 

end-user? 

Dr. SHUREN. Well, we have established a task force between FDA 

and CMS—NIH and CDC are also participating—to assure that we 

are not duplicating efforts. In fact, we have had conversations with 

certified laboratories, accrediting lab organizations under CLIA, 

two State licensure programs, and confirmed we are not duplicating efforts, but we do want to make sure we have good coordination moving forward. And we provide the education and information out for laboratories as well as we progress, so that work is 

happening in the task force right now. 

Dr. CONWAY. I agree. 

Mr. CA ́ RDENAS. Thank you. 

Mr. GUTHRIE. They gentleman’s time expired. And myself, and I 

think speaking for the entire subcommittee, we congratulate you on 

the good news and to your family, the next generation of your family, appreciate that very much. 

The Chair now recognizes Dr. Bucshon from Indiana for 5 minutes for questions. 

Mr. BUCSHON. Thank you, Mr. Chairman. 

Now, I have heard complaints that the FDA oversight of LDTs 

would interfere with the practice of medicine. I am a physician, 

cardiovascular surgeon, so I would like you both to comment as 

regulators but also as physicians on your view on that. 

Dr. SHUREN. So we do not—and as a physician, we do not regulate the practice of medicine. Congress actually put in a statutory 

provision prohibiting us from regulating the practice of medicine in 

the medical device program. It is a unique provision that pertains 

to us. What we are regulating, talking about regulating, are the 

tests, the things that we regulate already today, reagents, the instruments, the protocol, instructions are used that go forward with 

it. 

In fact, a group of laboratories who were working with the device 

industry, the conventional IVD makers, when they sat down and 

went through it, they began to realize, too, you know what, there 

59 

are parts here that is just like what happens in FDA: development, 

design, validation of tests. Then there are all these other activities 

that occur that are lab operations or the practice of medicine. They 

are not under our preview and we have never proposed to ever regulate those. 

Dr. CONWAY. And likewise, CLIA does not regulate the practice 

of medicine. It does regulate laboratories in terms of equipment, 

personnel, protocols, et cetera, which its focus is post-market laboratory by laboratory. 

Mr. BUCSHON. OK. Great. And currently, CMS regulates how 

physicians operates a lab, as you described, and performs tests 

within it, but I really haven’t heard any complaints about interfering with the practice of medicine myself from people that I 

know. Why is it that physicians feel differently maybe about the 

FDA oversight of these particular tests, and how can we address 

those concerns? Does that make sense? 

Dr. SHUREN. It does. I think what we are dealing with are people 

who haven’t dealt with us necessarily beforehand, and so it is new 

and they are assuming things that we don’t believe to be the case. 

I hearken back to Dr. Burgess, who I respect very much, when he 

said when CLIA came in the door you were not a fan, but you 

began to realize the value of it. I would say the same thing here. 

As the lab community works with us—well, maybe you will allow 

it. 

Well, hopefully, we will see much the same here with the lab 

community in working with us. And it is our hope they will work 

with us to make sure that when we are doing things, it also best 

fits for their operations. Again, we both are committed and care 

about that those tests work. 

Mr. BUCSHON. Yes. I mean I will just make a comment and I 

will—I mean, as a physician, obviously I want accuracy and patient 

safety to be at the top of the list, right? And again, I think Mr. 

Shimkus said I am not one that is generally for Government regulation, but I think in this area that, you know, this is a good discussion to be having on behalf of patients, and that I think the details and how things end up at the end are what are important. So 

I commend your hard work on trying to find the sweet spot as you 

go about your job. 

Thank you. I yield back. 

Mr. BURGESS [presiding]. The Chair thanks the gentleman. The 

gentleman yields back. 

The Chair recognizes the gentleman from Florida, Mr. Bilirakis, 

5 minutes for questions, please. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. I appreciate it. And 

this question is for the panel. 

As we go forward with any new regulation—regulatory scheme— 

we need to balance the needs between consistency, accuracy, and 

innovation. In disease areas such as cancer, genetic testing is 

evolving rapidly, and I am sure you agree with that. Many major 

institutions today have developed their own gene panels that help 

diagnose or identify potential treatments for cancer patients. 

For example, in Tampa we have the Moffitt Cancer Center, the 

only NCI-designated Comprehensive Cancer Center in Florida. 

They have developed a TruSight Tumor Gene Set, which is used to 

60 

identify lung and colon cancers that will benefit from targeted 

therapies. An advantage of the lab-developed tests is the ability to 

rapidly innovate current tests rather than the slower and expensive process of resubmitting to FDA for any changes. Centers such 

as Moffitt have the ability to innovate and rapidly improve their 

lab tests as fast as science evolves. 

Question: How can we resolve issues regarding consistency and 

accuracy and not stifle innovation in these labs and important 

healthcare institutions? 

Dr. SHUREN. So one issue for consistency, certainly we don’t—we 

were recommending not to have two duplicative systems out there, 

one under FDA, one under CMS, or we will have inconsistency. But 

then we have found that to assure consistency, we work with the 

community on trying to develop standards or in guidance so that, 

as we learn and the science evolves, we can have more of a common playing field of what performance should look like for certain 

kinds of tests. And that can help ensure consistency in terms of approach. 

Mr. BILIRAKIS. Thank you. Anyone else? 

Dr. CONWAY. I agree with Dr. Shuren, and I think, you know, 

from the CMS perspective, we think our strength is in that postmarket review laboratory by laboratory on the qualifications, 

equipment, and personnel. 

Mr. BILIRAKIS. Thank you. Anyone else want to jump in? OK. Dr. 

Conway, since both the volume and complexity of lab-developed 

tests on the market today have drastically increased in recent 

years, why hasn’t CMS asked for these new authorities? 

Dr. CONWAY. So in terms of authorities we think FDA has a critical role in premarket review of clinical validity. We think CMS’s 

role through CLIA really is and should be focused on laboratoryby-laboratory assessment, survey and certification and oversight of 

accrediting organizations, ensuring that the protocols, the equipment, and the standards are in place in individual laboratories in 

a post-market manner. 

Mr. BILIRAKIS. Dr. Conway, does CMS require definitive review 

of the clinical claims being made about the tests? 

Dr. CONWAY. And Dr. Shuren can certainly comment for FDA. 

On the CMS perspective, we do basic assessment of analytical validity so the analyte is the actual analyte in the test. We do not 

do assessments of clinical validity, meaning the test actually identifies the condition, the absence or presence of the condition it is supposed to identify. 

In our coverage process, we have occasionally looked at laboratory development tests for reasonable and necessary standard. 

There, we will look at the effect of the test on patients, but that 

is a very small number of LDTs we have looked at through that 

process. 

Mr. BILIRAKIS. Well, thank you very much, and I yield back, Mr. 

Chairman. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

The Chair recognizes the gentleman from New York, Mr. Collins, 

5 minutes for your questions, please. 

Mr. COLLINS. Thank you, Mr. Chairman. 

61 

Before I start my questions, I would ask unanimous consent to 

enter into the record a letter from Roswell Park Cancer Institute. 

Mr. BURGESS. Without objection. 

[The information appears at the conclusion of the hearing.] 

Mr. COLLINS. Thank you very much. 

In that letter they do mention the same we have talked about before, the Association of Molecular Pathology, or AMP, and their 

proposal, and I would certainly encourage the FDA, as we are in 

the discussion stage, to again take a look at this. 

So I guess one thing I am still trying to get clear on, you know, 

currently, a commercial test, something sold on the market which 

does have to go through FDA approval, premarket approval, and I 

assuming that is currently a 510(k)? 

Dr. SHUREN. For premarket, most of them are 510(k). A very tiny 

number are PMA. 

Mr. COLLINS. So as a 510(k) currently, it is a medical device subject to the medical device tax, correct? 

Dr. SHUREN. Yes. 

Mr. COLLINS. So if I understand what your guidance is now, you 

are going to move on IVDs out of that world, the medical device 

world, and have a different classification of class 1, 2, or 3, or low, 

moderate, whatever. Just a question, does that mean on the good 

news side that IVDs will no longer be subject to the medical device 

tax since they are not going to be getting 510(k)s? 

Dr. SHUREN. So the trigger for the device tax is registering at the 

listing with the FDA. What we have proposed for LDTs is that— 

and we use that to know what test is being made, who is making 

it, and that is a requirement by law. But we have worked through 

that instead they can give us a notification and not list with us, 

and particularly—and that is for starters. And for the tests that 

don’t ultimately come in for premarket review, they also wouldn’t 

end up registering and listing with us. And that would not trigger 

the device tax. 

Mr. COLLINS. So current tests would be still covered by the medical device tax even though there is not a 510(k) because they 

would be listed with the FDA? 

Dr. SHUREN. They are registered and listed with that, and those 

are—— 

Mr. COLLINS. OK. That clarification is important because I have 

heard that kind of going all over the board. 

Now, another, you know, concern has been, you know, accuracy 

of testing, and I think it is also important to make clear laboratorydeveloped tests are not sold to other facilities. They are used inside 

a facility such as Roswell Park, which is looking at very specific 

treatments for specific cancers and what we call personalized medicine. They are not then selling those tests to other folks or making 

claims, which is different than a commercialized test, which currently goes through FDA approvals. 

But, you know, Dr. Conway, it is my understanding that over 97 

percent of the CLIA laboratory test facilities have subjected themselves to outside third-party proficiency testing of their tests. Isn’t 

that correct? 

Dr. CONWAY. So proficiency testing occurs in just 13 specialty 

areas, occurs approximately three times per year. It has improved 

62 

the accuracy over time. It will not assess for clinical validity of the 

test, so the premarket clinical validity, which Dr. Shuren spoke to, 

the proficiency testing does not analyze clinical validity. 

Mr. COLLINS. Well, it certainly analyzes whether you are properly getting—you know, you are identifying the antigen you are 

supposed to identify. 

Dr. CONWAY. So it will identify—if that laboratory-developed test 

was within those 13 categories, which they are not all within those 

13 areas, but for an LDT that was in one of those 13 areas—and 

Dr. Shuren may say more—it will detect that the analyte is the 

analyte, but that is not an assessment of the clinical usefulness or 

validity of the test. 

Dr. SHUREN. And it goes to again, if you will, the accuracy of the 

performance of the test as opposed to the accuracy of the test itself, 

which is a different look, and that is what we look at for the test. 

Mr. COLLINS. Yes. I guess I would just say it is my belief anyway 

that the laboratory-developed tests, certainly in institutions like 

Roswell Park, are being done to get better treatment, quicker treatment to the patients. And a big concern all of us have, if this goes 

through, that a test might be used tomorrow to help a patient with 

cancer now is delayed 6 months as it goes through some kind of 

premarket review at FDA, which is a life-and-death situation for 

many of these cancers. 

And I think it goes back to—I think I go on to the same bandwagon as Mr. Barton and Dr. Burgess. This has not been a problem 

that I would identify, and putting any type of delay into this 

sphere of personalized medicine and treatment especially in the 

cancer and oncology world runs the risk frankly of causing people 

to die that don’t need to die, treatments that could be given that 

would be delayed. And in the cancer world, delay is not a good 

thing. 

So personally, I would throw myself into the category I believe 

it is working now. We do have outside proficiency testing, thirdparty testing. And we have to remember these are laboratory-developed tests that are not being sold in the marketplace to other facilities, which is very different than what you are doing now. 

My time has expired, but if the Chair would like to hear a response, I would certainly yield a couple seconds. 

Mr. BURGESS. Sure. He is recognized for a response. 

Dr. SHUREN. I truly appreciate those comments because we do 

not want to stifle innovation in this place. We want to have patients get timely access to tests. And that is why even under an 

FDA mechanism if the test is being reviewed, it is being developed, 

it can still be made available to patients on an investigational basis 

or for compassionate use. But there at least you are telling the doctor and you are telling the patient we haven’t validated this test 

yet. It is investigational. This may be—— 

Mr. COLLINS. You know what, I appreciate that because my 

worry was they would develop a test, they couldn’t use it until they 

had approval, but if on an investigative basis they know that—they 

think they have a good test they can use it, then you have actually 

helped me in a couple of ways there. Thank you for that response. 

I yield back. 

63 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

The Chair recognizes the gentleman from Pennsylvania, Mr. 

Murphy, 5 questions for questions, please. 

Mr. MURPHY. Thank you. Doctor, Doctor, it good to have you 

here, appreciate this. 

I want to pivot a little bit here to talk about piecing together 

post-market and premarket analysis to look at this, and in particular, a couple of devices used in women’s health care, one is 

called a morcellator. Are you familiar with the morcellator, a device 

that is supposed to shred tumors, et cetera, but has been associated 

with complications in women in terms of actually spreading cancer 

for them? 

Now, it has been on the market for 20-plus years, and the FDA 

admitted for the first time it became aware of the safety issue with 

power morcellators was after December of 2013, correspondence 

from a physician citing the case of a family member. This is someone who had just recently had another surgery to remove another 

recurrence of cancer that was spread it by the morcellator. 

The manufacturer was apparently aware of the dangers of this 

device as early as 2006 based upon a report from Dr. Lamparter, 

a pathologist from central Pennsylvania, who cited about 1 out of 

300 samples of morcellated tissue from his hospital had evidence 

of a hidden cancer, which is morcellated. 

So my question is did the FDA have any evidence of these dangers in 2006 or prior to that? Are you aware of this problem? 

Dr. SHUREN. So in the past the thought was what risks of cancer 

there may be for a fibroma—for a fibroid actually to have cancer 

in there—were significantly less. And one of the things when we 

looked into it more recently we came to a different conclusion, that 

the likelihood of cancer is higher. There is still disagreement in the 

community because, as you know, the healthcare professional societies disagree. They think we have overestimated the risk of cancer. 

We said we have a different perspective, and that is why we 

went out and we put contraindications and warnings on the use of 

that device, that it should only be used in a more limited set or 

offered as an option in a limited set of women and think about primarily women who, in the absence of using the device, would no 

longer be able to bear children but they want to bear children. And 

we felt those cases the risk of the cancer is very low. They should 

have the opportunity to weigh in, but we scaled back dramatically 

how that should—— 

Mr. MURPHY. So this is a case where the science available, the 

premarket analysis has changed, and what is being used in the 

data, you have a mechanism to go forward on this and make some 

changes. Let me ask another question. 

Brigham and Women’s Hospital was aware of the dangers in 

2012. A patient by the name of Mrs. Erica Katz was seriously injured in 2012 by the device and then died in 2013 according to reports. I wondered, do you know if that hospital reported that to the 

FDA? Would you know? 

Dr. SHUREN. I am not aware that—— 

64 

Mr. MURPHY. Is there a mechanism where the hospital is supposed to report that or the manufacturer is supposed to report that 

so you can do the analysis? 

Dr. SHUREN. So user facilities have certain requirements for reporting. So do manufacturers if they become aware of certain 

events. And what I can tell you is we have been looking into those 

concerns that have been raised regarding reporting. 

Mr. MURPHY. OK. In response to congressional inquiries about 

this, the FDA admitted that the 1-out-of-350 risk does not address 

other types of malignancies, which you would add to that risk, you 

said. They went on to say the FDA also identified studies showing 

that morcellated patients had worse outcomes than patients who 

had not undergone morcellation. 

So this is more than just the issue with just a fibroid or if it is 

cancerous. It is also a question of outcomes. Is this something that 

the FDA is reviewing also with regard to their stamp of approval 

on these things in terms of the outcome measures? 

Dr. SHUREN. So in terms of the tests we have looked at, we think 

where we have constrained it right now is—for use is where the 

benefits outweigh the risks, but we are continuing to look at new 

data as it arises, and if so, we will act accordingly. 

Mr. MURPHY. Thank you. There is another issue in women’s 

health that was brought to my attention. It is a product called 

Essure. It is a permanent birth control device that went through 

FDA’s rigorous premarket approval process. Yet despite getting the 

agency’s approval, it has been linked to at least four deaths and 

deaths of five unborn children. Apparently, a total of 24,000 women 

have come forward claiming that they have been harmed by this 

device. And so the question is how it remains on the market with 

a potential for problems. And because this has the FDA stamp of 

approval, these women feel at this point they cannot take their 

cases forward, and they feel they don’t have any recourse. Is the 

FDA also reviewing this issue as well as far as you know? 

Dr. SHUREN. We are. In fact, we held an advisory committee 

meeting a few weeks ago at our behest to give an opportunity to 

put what new evidence is on the table to assure that people who 

wanted to raise concerns about it had an opportunity to provide 

those concerns. And we are now currently reviewing the feedback 

we received from the advisory committee, as well as what we have 

heard from other people, as well as the state of the evidence, and 

we will come out with our conclusions on that to the public. 

Mr. MURPHY. Thank you. And as this goes through, since this 

hearing has been a lot about premarket analysis, what this comes 

down to is I just want to make sure that we are aware of what 

mechanism you have, because I understand the science of 1996 is 

different from the science of 2015 and our knowledge base, but to 

have an ongoing mechanism for review and changes, devices and 

getting information there and looking at those things, I mean, I am 

glad you had some hearings on this, but I would certainly like to 

know that that is part of the system. 

I am out of time, but I look forward to hearing your comments 

on that in the future. Thank you. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. 

65 

1The information has been retained in committee files and also is available at http:// 

docs.house.gov/meetings/IF/IF14/20151117/104127/HMTG-114-IF14-20151117-SD009. 

The Chair recognizes the gentleman from Texas for a unanimous 

consent request. 

Mr. GREEN. Mr. Chairman, I ask unanimous consent to place in 

the record ‘‘Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies.’’ I ask unanimous consent 

to place that in the record. 

Mr. BURGESS. Without objection, so ordered.1

Mr. BURGESS. And I recognize myself for an additional unanimous consent request to add the statement of the American Association of Clinical Chemistry to the record. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. BURGESS. Seeing no further Members wishing to be recognized for questions, I do want to remind Members they have 10 

business days to submit questions for the record, and I ask the witnesses to respond to those questions promptly. Members should 

submit their questions by the close of business on December 2. 

With that, the subcommittee stands in adjournment. 

Dr. SHUREN. Thank you. 

[Whereupon, at 12:07 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

The 21st Century Cures Act passed this committee 51–0 and was through the 

House in July with 344 votes. It was the product of over a year’s worth of ideas 

Members received at hearings, roundtables in DC and across the country. Provisions 

were proposed and fleshed out with the help of a wide variety of stakeholders, in 

and out of Government, of all political stripes. It goes without saying that for any 

piece of comprehensive legislation to garner these vote totals, compromise is critical 

and the perfect can’t become the enemy of the good. It also goes without saying that 

some important pieces of the puzzle didn’t get included because the timing just 

wasn’t right. Modernizing our regulatory framework for the review and oversight of 

diagnostics is one of those pieces. 

As I said at our first forum on this topic in July 2014, these increasingly important and complex tests are providing researchers and clinicians with valuable tools 

to match the right patients with the right treatments. We must ensure that our 

laws and regulations keep pace so that innovation in this space continues and patients benefit from accurate and reliable tests. 

I saw Cures as a unique opportunity to elicit feedback on what such a framework 

should look like and what role Congress could play in developing it. We issued a 

white paper asking targeted questions and were overwhelmed with the scope and 

thoroughness of the responses we received. We realized early on that the traditional 

medical device framework was not ideally suited for these unique tests, which provide clinicians with critical information but do not actually provide therapy to a patient. 

It was also apparent that there was quite a difference of opinion about what the 

roles and responsibilities of FDA and CMS should be. Developing legislative language with broad support on an abbreviated timeframe was not achievable. I told 

my staff to table these discussions until we got Cures through the House but to urge 

stakeholders to use the time to forge ahead and find as much common ground as 

possible. 

I was very encouraged to hear that a diverse group of stakeholders with different 

points of view came together and, in the spirit of finding consensus, developed a 

draft framework that answered a lot of our questions in a responsible, balanced 

manner. Of course there is room for improvement, but folks need to be realistic in 

their approach and pragmatic with their suggestions if the ultimate goal is a bill 

signed into law any time soon. We must get this right and we need everyone’s help 

in order to do so. 

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PREPARED STATEMENT OF HON. RENEE L. ELLMERS

Earlier this year, Democrats and Republicans on the House Energy and Commerce Committee worked together to develop the 21st Century Cures legislation. I 

was proud to work with my colleagues on that landmark initiative in order to reduce regulation, inspire innovation, improve outcomes for patients and move our 

country towards precision medicine. Further, that legislation helped highlight the 

increased importance of diagnostics in modern health care. 

Today, diagnostics play a critical role in the rapid detection and diagnosis of diseases. Diagnostics help identify targeted, effective and often less invasive treatments-ultimately leading to reduced costs to both patients and the Government. 

The Committee’s current discussion draft legislation follows the work of 21st Century Cures and focuses on the future of diagnostics. It would advance innovation, 

protect patients, provide a predictable and timely path to market and avoid duplicative regulation. It does this by tailoring an appropriate role for the FDA (outside 

of the medical device framework) to oversee diagnostic test development activities, 

while modernizing CLIA oversight of separate and distinct laboratory operation activities. 

Without this legislation, I am concerned that the FDA would finalize guidance to 

regulate laboratory developed tests as medical devices, which could impact many 

stakeholders. This guidance may lead to costly litigation and uncertainty or could 

hamper innovation and patient access to critical diagnostic tests. 

Also, I am deeply concerned that this guidance would result in the medical device 

tax being imposed on laboratories. Dr. Shuren confirmed during the hearing in September 2014, that under the FDA’s guidance, labs would ultimately be directly subject to this medical device tax. Labs already pay the tax indirectly when they purchase test kits from manufacturers, so under the guidance they would unfairly pay 

the same tax twice. 

I have many stakeholders in my district, so this discussion draft legislation represents a good compromise between the CLIA-centric approach and the medical device framework laid out in the FDA guidance. In addition, my district is home to 

many veterans and military families who rely on TRICARE for their health care, 

so ensuring market stability and access to these crucial tests directly affects my constituents. 

I am thankful for stakeholder engagement in finding a legislative solution that 

provides a feasible alternative to FDA’s draft guidance. I stand prepared to work 

with the chairman and ranking member in order to accomplish this goal. 

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