TESTIMONY OF THOMAS A. SCULLY ADMINISTRATOR CENTERS FOR MEDICARE & MEDICAID SERVICES ON AMBULATORY ASSISTANCE DEVICES AS WELL AS CLINICAL LABORATORIES BEFORE THE HOUSE COMMITTEE ON SMALL BUSINESS AND THE SUBCOMMITTEE ON REGULATORY REFORM AND OVERSIGHT

Chairman Manzullo, Congresswoman Velázquez, Chairman Pence, Congressman Brady, distinguished Committee members, thank you for inviting me to discuss the Centers for Medicare & Medicaid Services' (CMS) evaluation of ambulatory assistance devices as well as clinical laboratories.  As you know from my previous testimonies before this committee, President Bush, Secretary Thompson, and I are strongly committed to protecting the health and safety of this nation’s most vulnerable citizens – the sick, the poor, the elderly, and the disabled.  We also are dedicated to safeguarding the taxpayers’ money in the Medicare trust funds, and to tearing down regulatory burdens for small businesses.  We believe small businesses are critical to the future of our country, and I want to continue working with you to meet their needs so that they can continue to provide high quality care for Medicare beneficiaries. 

 

Small businesses provide a variety of health care services.  They include individual physicians, small group practices, and providers of durable medical equipment, orthotics, and other supplies and services.  They help to ensure that Medicare beneficiaries receive the care they need and play a vital role in the Medicare program.  I recognize the importance of helping small businesses continue to fill this need.  Since I took over as CMS Administrator, my number one priority has been to improve the Agency's responsiveness and make it a better business partner.  At CMS, we are committed to simplifying our rules, making them easier to understand and less burdensome.  We also are committed to opening up CMS and creating more ways for the entities we regulate – including small business – to interact with us.  This helps all sectors of the health care industry, of course, but we are paying particular attention to small business providers.

For example, one way we are making the Department, and CMS in particular, more open and accessible is through the Secretary’s Advisory Committee on Regulatory Reform, which we created last summer and includes patient advocates, providers, and other health care professionals from across the nation.  This Advisory Committee helps to guide the Secretary’s efforts to streamline unnecessarily burdensome regulations and to eliminate inefficient regulations that interfere with the quality of health care for Americans.  I know that you, Mr. Pence, and your Subcommittee have a particular interest in the Advisory Committee’s suggestions on clinical laboratories, and I will discuss those in more detail in a few moments.

 

We also have created 11 "Open Door Policy Forums" to interact directly with beneficiary groups, providers, suppliers, physicians, and health plans to strengthen communication and information sharing between stakeholders and the Agency.  These regular forums are open to all providers – rural, urban, small, large, for-profit, and nonprofit – and to the public.  Many of these groups include small business providers.  Outside groups meet with senior CMS staff on a regular basis, most of them monthly, to bring to our attention those nagging little problems that they encounter when dealing with the Medicare and Medicaid programs. 

 

We also are working directly with physicians and other health care providers to improve our communications with them and ensure that CMS is responsive to their needs.  We are providing free information, educational courses, and other services through a variety of advanced technologies.  In particular, we have a broad selection of training materials available on our Medicare provider education website, www.cms.gov/medlearn.  This site provides timely, accurate, and relevant information about Medicare coverage and payment policies, and serves as an efficient, convenient education tool for all providers, including small businesses. 

 

As someone who has worked on health care issues in both Bush Administrations, as well as in the private sector, I know how frustrating Medicare's complex regulations can be.  Simplifying the requirements and generally making Medicare a better business partner has been a top priority of mine for years.  This Administration takes very seriously the importance of assessing the impact of its decisions on all Americans, including small business owners, and I look forward to continuing to work with you to further improve the system. 

                      

CODING AMBULATION DEVICES ON THE MINIMUM DATA SET

Quality of Care

Over the last few years, at CMS we have focused intently on improving the quality of care for Medicare beneficiaries across the health care industry, including the nursing homes where nearly 3 million Americans receive care.   Most recently, we began publishing quality data on individual nursing homes in six pilot States, and we plan to expand this project nationwide.  Our goal is to educate beneficiaries and their families so that they can better compare their options and make the best choice for their own or their loved ones’ care.   To this end, we are publishing information about how individual nursing homes perform in nine measures of quality that were recommended by a broad-based committee of the National Quality Forum, an independent standard-setting organization representing public and private purchasers, consumers, providers and researchers.  The nine measures are designed to help consumers make and “apples-to-apples” comparison of nursing homes.  We are strongly committed to ensuring these Americans receive the excellent care they deserve and enjoy a high quality of life. 

 

I recognize that ambulation assistance devices like the Merry Walker ® Ambulation Device are intended to help improve the quality of life for nursing home residents and others who face reduced personal mobility.   This is a noble effort and I appreciate the people, including my fellow witness, who are working hard to create new and improved ways of enhancing mobility for these residents.  I believe that there are numerous instances where these ambulation devices are used appropriately every day.  However, I also am aware that there are some instances where devices like the Merry Walker® Ambulation Device are used in ways other than those intended by their manufacturer.  While these devices are meant to help people become more independent, sometimes nursing homes uses them in ways that restrict the resident’s freedom of movement and, in fact, can pose a serious and dangerous threat to the health and safety of some Medicare and Medicaid beneficiaries. 

 

Results of Working Together

I have directed my staff to work closely with you to examine the way that ambulatory assistance devices like the Merry Walker® Ambulation Device are coded on the Minimum Data Set (MDS).   We have met with Chairman Manzullo and communicated often and in detail about this issue.  In fact, since in mid-June, when my staff met with Chairman Manzullo and Ms. Mary Harroun, whose company manufactures the Merry Walker®, over 40 e-mails and tens of hours of phone calls between our staffs have occurred, with the ultimate goal of streamlining our guidelines while ensuring compliance with the statutory requirements and resident safety. 

 

As a result of these interactions, CMS has proposed changes to our Guidance to State Surveyors, and our Resident Assessment Instrument (RAI) Manual.  The Committee’s Regulatory Counsel approved these changes in July, and CMS sent proposed RAI changes for review by industry to ensure that the changes are understandable.  These changes focused on the requirement that nursing homes assess whether a device, such as the Merry Walker® Ambulation Device, have the effect of restraining an individual.  This change would alleviate the concern that facilities improperly code the Merry Walker® as a restraint in every instance, without doing an individual assessment.  I am pleased with the level of cooperation we have achieved to ensure that devices are coded correctly on the MDS assessment tool and that  nursing home residents are properly assessed and cared for without being put at risk.  Although I understand Chairman Manzullo still has concerns that these changes do not go far enough, it is only when we work together in this fashion can we have the most appropriate impact and create the greatest good.  I look forward to continuing to work with you in this manner.

 

Legal Requirements

The Nursing Home Reform Act of 1987 state that the resident has "the right to be free from … any physical or chemical restraint imposed for purpose of discipline or convenience and not required to treat the resident’s medial symptoms.   Restraints may only be imposed (I) to ensure the physical safety of the resident or other residents and (II) only upon the written order of a physician that specifies the duration and circumstances under which the restraints are to be used.”  CMS defines a physical restraint in a nursing facility as “any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident’s body that the individual cannot remove easily that restricts freedom of movement or normal access to one’s body.”  As described below, in one section of the MDS nursing homes are required to answer whether the facility uses a restraint on a particular resident.

 

The Minimum Data Set

The MDS is part of our Resident Assessment Instrument, which is used to develop a comprehensive assessment for all residents in a long term care facility certified to participate in Medicare and Medicaid.   Specifically, the MDS is a set of screening, clinical, and functional elements that helps to give staff a better understanding of the health status of each resident.  As a screening tool, the MDS helps nursing home staff to identify possible problems that need to be addressed in a resident’s individual care plan.  As part of this assessment, we capture information on any device that meets the definition of restraint.  That includes recognizing any time a device like the Merry Walker® Ambulation Device meets the definition of restraint for an individual resident. 

 

We have focused on improving how facility providers code information on our MDS form.   Providers use the data from the MDS as a part of the assessment and care planning process required by law for residents in nursing homes certified for Medicare and/or Medicaid .  The current version of the MDS was developed in 1995 with considerable input from countless individuals representing associations, beneficiary groups, and State governments with which we have worked in partnership in implementing the MDS nationally.  We recognize the value of including different perspectives and areas of expertise in establishing clinical guidelines and plan to continue this open and inclusive approach with refinements to the MDS to streamline it and get nursing staff back to the bedside and caring for residents, not filling out paperwork.

  

I understand this Committee is concerned about how ambulation devices like the Merry Walker® Ambulation Device are coded on the MDS.   Evaluators code ambulation devices as a mode of locomotion and/or a physical restraint, depending on how the device impacts the individual resident.  As noted above, the Nursing Home Reform Act guarantees nursing home residents freedom from restraints being used for the convenience of staff.  Our State Operations Manual, which guides state surveyors, defines a physical restraint as any “device, material, or equipment attached or adjacent to the resident’s body that the individual cannot remove easily that restricts freedom of movement ….”  If a nursing home resident cannot open the front gate on an ambulation device due to physical or cognitive limitations, and so cannot exit the device, the device restricts the resident’s freedom of movement, and must be coded on the MDS as a restraint.  Conversely, if an ambulation device were not restrictive for a resident, it would not need to be considered a restraint. 

 

The Merry Walker® assessment sheet itself recognizes the distinction between when the device is a restraint and when it is not.   The written materials accompanying the Merry Walker® state: “If a resident can remove himself/herself from the Merry Walker then it is not a restraint.”  We agree and have instructed nursing home providers to code this device as a restraint only in those instances where the resident cannot remove himself from the device. 

 

Statutory Requirements for Using a Restraint

Even if the device meets the definition of a restraint for an individual resident, that would not necessarily prohibit the device’s use.  If there is a medical symptom that warrants the use of the restraining device, the resident could still use it, provided that a physician prescribes its use.  The law prohibits the improper use of restraints in order to ensure that nursing home residents retain their right to be free of restraints for discipline or convenience of the nursing home’s staff.  It is permissible and appropriate, however, to use restraints when treating a medical condition or to ensure the safety of the resident.  The nursing home, in conjunction with a physician, must perform an assessment to identify the medical symptoms the restraint would be employed to address.  The assessment should take into consideration the professionally and medically recognized risks of using the device versus the potential risks of not using the device for that particular resident.

 

State Surveyors Citations Involving the Merry Walker®

Recently we reviewed state surveyors’ citations delineating the inappropriate use of restraints over this past year.  Of the 6,103 citations written by surveyors for inappropriate physical restraint use, approximately 30 involved the use of the Merry Walker® Ambulation Device or similar device, or less than one half of one percent.  These numbers suggest that state surveyors understand the regulations involving physical restraints and generally have correctly cited facilities for improper use of the Merry Walker® Ambulation Device.   More importantly, our review of the citations indicates that for the vast majority of the time the Merry Walker ® Ambulation Device does not meet the definition of a restraint.  If the device should be considered a restraint for a particular resident, facilities are properly assessing the device, monitoring its use, and following the rules set out in law involving when a physical restraint can be used.

 

It is incumbent upon facilities to properly assess whether this device meets the definition of a restraint for a particular individual, and this assessment must be ongoing.   When a resident cannot exit the device on his own accord, additional oversight of the resident is required.  Some of the deficiencies found by state surveyors involve the Merry Walker® Ambulation Device as a restraint.   In some cases the device caused actual harm to the resident.  These cases highlight the need for CMS to be vigilant in protecting nursing home residents from the inappropriate use of restraints.  

 

Injury Sustained While in the Merry Walker® Because of Inappropriate Use or Inadequate Supervision

Some surveyors found cases of residents who could not open the gate on the Merry Walker® being injured as they attempted to get out of the Merry Walker® Ambulation Device by crawling out from under the gate or trying to climb out over the top of the gate.  In other cases, the residents were injured while using the Merry Walker® Ambulation Device.   When properly used, the device prevents falls (as the manufacturer intended).  However, without appropriate supervision, particularly when the device limits the resident’s freedom of movement, significant harm may occur.

 

• One state surveyor uncovered an instance in which a resident had fallen on six separate occasions while using the Merry Walker®.  The resident attempted to get out of the device by sliding out from under the gate, since she had such difficulty opening the gate and exiting the device.    In the same facility, a resident fractured her arm when she tried to climb out of the Merry Walker® Ambulation Device, and another a resident fractured his hip while trying to climb out of the device.
• Another example of actual harm involving the Merry Walker® Ambulation Device included a case in which the survey team heard the resident yelling for help.  The surveyors found the resident lying partially across the bed.  The resident’s foot and leg were caught in the seat strap of the Merry Walker®.  While his foot remained trapped in the device, the Merry Walker® began rolling away from the resident, putting him at risk of being pulled to the floor by the ambulation device.  Interviews with staff confirmed the resident had tried to get out of the Merry Walker® on other occasions and had sustained falls while in the Merry Walker®.
• One resident overturned the device and was found on the floor with the device on top of him.  The resident was injured by the fall.  Despite his repeated falls while in the device, staff continued to state the device was used to prevent falls and failed to reassess the resident’s needs.  In this case, a staff member admitted that the use of the restraint without assessment could pose the risk of death or serious physical harm, and concluded that facility should have assessed the resident’s use of the Merry Walker®.  The staff member noted that the use of the restraint without assessment could lead to functional decline (such as incontinence) for a resident.  Review of the record revealed that by the time the facility assessed the resident occurred, the resident had sustained multiple falls, needed greater assistance in locomotion, and had become incontinent of bowel and bladder. 

 

Improper Use of the Merry Walker® for Staff Convenience

The Nursing Home Reform Act prohibits the use of a restraint for staff convenience.   State surveyors uncovered instances of where nursing home staff used the Merry Walker® to keep residents from wandering.  When a resident is unable to open the gate on the Merry Walker® Ambulation Device without assistance or does not understand the instructions given by the staff on how to open the gate on the Merry Walker®, staff may not place the resident in the Merry Walker® for convenience. 

 

• State surveyors cited one facility for restraining a resident in a Merry Walker® Ambulation Device for staff convenience.  The Merry Walker® kept the resident from leaving the building.  Surveyors found that staff would leave the resident in the Merry Walker® when they could not supervise her, even though the staff had not assessed the appropriateness of the resident’s use of the Merry Walker® and staff had not identified the use of the restraint on the resident’s care plan.  A certified restorative aide and charge nurse revealed that the resident did not need restorative services because the resident was able to walk without the use of the ambulation device.  However, staff noted that the resident could not exit the device on her own, but she would attempt to get out of the Merry Walker®, because the Merry Walker® agitated the resident.
• State surveyors cited a facility for placing a resident in the Merry Walker® all day, including leaving the resident in the device for meals.  The staff would place the resident’s meal tray on the Merry Walker®.  The staff admitted they did to restrain the resident, who could not exit the device without assistance. When not in the Merry Walker®, the resident would attempt to get up leave the table and walk around. 

 

CMS does not prohibit the use of restraints, but rather establishes procedural safeguards to protect residents from their overuse.  We acknowledge that there are situations where restraint use is both appropriate and necessary.  When the Merry Walker® is considered a restraint in a particular instance, it may be properly used with a plan of care.  However, as the above examples make clear, the protections required are appropriate for those instances in which the Merry Walker® meets the definition of a restraint.  The examples of the device’s inappropriate use and/or inadequate supervision caused injury to the resident emphasize why we focus on the effect the device has on the resident and not merely the manufacturer’s intent on making the device.  While we are strongly committed to our efforts to support small businesses, we have an obligation to uphold the statutory right of a resident to be free from a restraint that is used for staff convenience or where the medical symptoms do not warrant.

 

While I have cited a number of instances where these ambulation devices have endangered nursing home residents, I am certain there are numerous instances where the devices have had very positive impacts on the lives of residents.   We want to increase the number of positive stories and decrease the instances of risk to nursing home residents.  One way we can do this is to ensure nursing homes follow the statutory mandate that they complete comprehensive assessments and provide individualized plans of care for each resident.  In this way, we can help facilities understand what constitutes a restraint and understand when restraint use is appropriate and inappropriate.  We have been working hard to simplify our procedures and make Medicare a better business partner for health care providers so they can better understand their responsibilities and have more time to care for our beneficiaries.  

 

We require nursing home evaluators to determine whether devices like the Merry Walker® Ambulation Device should be coded as a restraint based on its effect on each individual resident.  This enables us to better ensure that we are protecting the resident’s right to be free from the inappropriate use of restraints as mandated by the law.  We are doing everything we can to make it easier for health care professionals in nursing homes to provide appropriate care for their residents -- including improving our working relationships with small businesses while maintaining regulations that are in the best interest of nursing home residents and the taxpayers.  As I said earlier, I appreciate this Committee’s dedication to that end, and I look forward to continuing to work with you in this effort.   

 

CLINICAL LABORATORY REGULATION

In addition to ambulation assistance devices, at CMS we also regulate clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA).  A precursor to CLIA was passed in 1967 with CMS’s regulatory responsibility limited to those laboratories that participated in the Medicare and Medicaid programs, and laboratories that tested specimens in interstate commerce.  Congressional hearings over the concerns about deaths of women from erroneously read Pap smears and the proliferation of bench top laboratory technology into non-traditional testing sites led Congress to amend the original CLIA law.

 

In 1988, Congress passed CLIA, expanding CMS’s responsibility to include all laboratories that test human specimens “for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.”   We implemented those changes in 1992 with the publication of a final rule with comment period.   The law sets minimum uniform quality standards for all clinical labs and was passed with broad bipartisan support.  It is an important program that helps to protect all patients, including Medicare beneficiaries, by encouraging accurate, reliable lab test results and timely reporting of those results. 

 

We know one way to make a program like CLIA even more effective is to make it more user-friendly for providers.  That is why we have worked hard to streamline procedures, improve flexibility, and reduce burdens on labs.  We also are working to take into consideration the tremendous amounts of feedback we have received on the 1992 rule so that we can publish a streamlined final rule in the near future.  We think this will be especially helpful for the small business labs that many Medicare beneficiaries and others rely on for their health care needs.  

 

CLIA regulations are based on the complexity of tests, not the type of lab or where the testing occurs.  Labs performing similar tests must meet similar standards, whether located in a hospital, doctor's office, or other site.  Under CLIA, there are three categories of tests: waived tests, moderate complexity tests, and high complexity tests.  The most frequently performed tests in physicians’ office laboratories are waived tests -- simple tests with small chance of error or risk – which are exempt from routine surveys and virtually all CLIA rules.  Labs performing only these tests are referred to as Certificate of Waiver (COW) labs.  Although exempt from many rules, they must enroll in CLIA, pay a certification fee, and follow the test manufacturer’s instructions. 

 

Moderate and high complexity tests are subject to a number of CLIA requirements, including:

• Personnel:  CLIA sets minimum qualifications for all persons performing or supervising moderate or high complexity lab tests.
• Proficiency testing:  Labs must also participate in an approved proficiency testing program, which provides an external evaluation of the accuracy of the lab’s test results.
• Quality control:  Labs must have a process for monitoring personnel, testing equipment, and the testing environment to ensure proper operation and accurate results.
• Quality assurance:  Labs must have and follow a plan to monitor, on an ongoing basis, the overall operation of the laboratory, provide communications and resolve problems that affect the quality of their testing.  
• Cytology testing: CLIA sets special rules for cytology testing including workload limits, individualized proficiency testing and personnel standards, and quality control procedures.

 

Data show that these regulations are helping.  Since CLIA was implemented in 1992, quality deficiencies on clinical labs overall have decreased significantly.  The first onsite surveys of labs revealed that up to 35 percent of labs had quality issues.  At this time, less than 9 percent of labs have quality problems.  We believe that our educational rather than punitive approach has facilitated improvement in lab quality.  Data from our Survey Evaluation Form show that most laboratories respond very positively to the educational, information-sharing approach to oversight.

 

However, despite these improvements, the potential for safety-jeopardizing problems still exists, as shown in recent data on waived labs that are not routinely overseen.  For example, under the CLIA program, we conducted an initial pilot study in the States of Colorado and Ohio, with on-site visits to a random sample of 200 labs that are exempt from many CLIA requirements.  Significant quality and certification problems were identified in over 50 percent of these laboratories.

 

We expanded this pilot to include eight additional States to verify the scope and seriousness of Colorado’s and Ohio’s initial study findings.  As a result of this expanded pilot, quality problems were identified that corroborated the initial study findings, which included:

• 32 percent failed to have current manufacturer’s instructions for the tests they performed;
• 32 percent didn’t perform quality control as required by the manufacturer; and
• 16 percent failed to follow current manufacturer’s instructions.

Recent studies conducted by the CDC, HHS Office of Inspector General, and New York have produced similar findings. 

 

Due to the significant increase in the number and types of tests waived, the rapidly expanding number of laboratories with no oversight, and the serious findings in COW laboratories, in April 2002 we notified State Medicaid Directors, organized medicine, professional organizations, and accrediting organizations that we would begin working with labs that are exempt from CLIA requirements to help ensure higher quality care.  We are using an educational approach to help them enhance their basic lab practices and improve testing accuracy so they can better serve all Americans.

 

We started visiting 2 percent of the COW laboratories on April 15, 2002.  The laboratories are notified in advance, first by letter and then by telephone, to confirm the on-site visit.  The visits focus on the education of testing personnel to ensure quality testing.  If quality problems are found, we provide assistance to the laboratories to help ensure they are able to achieve accurate and reliable results.  There is no fee charged to the laboratories at this time for these visits, and we are pleased that our preliminary follow up data from our expanded pilot studies indicate this educational approach to be highly effective.  Moreover, we are beginning to explore and develop other educational efforts for these laboratories to further help them improve the quality of services that they are providing to Medicare beneficiaries and others. 

 

In addition to this educational approach, I want to mention a few of the other ways we have worked to reduce burden for providers, including many small business providers, that are subject to CLIA rules, as well as some ideas we have for future initiatives.  Ninety-seven thousand, or 60 percent of all labs registered under CLIA, are small physician office labs (POLs).  Although most of them face minimal regulation under CLIA, or have virtually all of their requirements waived, 22 percent of the POLs perform moderate or highly complex procedures that, if done incorrectly, could place patients at significant risk.  So we have taken numerous steps over the years to help relieve burden for them.  For example, in 1993, soonafter CLIA was implemented, we defined a sub-category of moderate complexity tests, now called "provider-performed microscopy" (PPM), that are exempt from routine inspections under CLIA.  In 1995, we expanded the PPM sub-category to many more labs by allowing dentists and mid-level practitioners to perform PPM tests, in addition to physicians.  In fact, our data indicate that there are now more POLs enrolled in CLIA than there were at the outset.  A 1997 OIG study about CLIA and access to laboratory testing likewise concluded that there had been no loss of access as a result of the CLIA regulations.

 

Of course, many labs that perform moderate or high complexity tests are not exempt from CLIA requirements, and for them CLIA is flexible in providing options for how quality standards may be met by allowing a number of options for private accreditation and State certification.  Accrediting organizations currently approved by HHS for this purpose include COLA (formerly Commission on Office Laboratory Accreditation), the Joint Commission on Accreditation of Healthcare Organizations, and 4 others.  Moreover, labs in States that approve or license labs under standards at least as stringent as CLIA are exempt from CLIA requirements.

 

To further help labs that are subject to CLIA inspection, we revised our survey procedures so that labs with excellent compliance records and proficiency testing scores will be inspected on-site less frequently.   These labs may complete a self-assessment questionnaire in lieu of an on-site inspection in every other 2-year survey cycle, so they would be inspected on-site only every 4 years.  Laboratories selected for this “honor” frequently comment how proud they are to receive this recognition. Furthermore, our surveys focus on lab practices directly related to the accuracy of test results or potential risk to patients, not impractical, burdensome requirements.

 

We also gradually phased in our personnel provisions to assure adequate time for lab staff to qualify. Most physicians already met all of the required qualifications.  Moreover, regulations published in 1992 and 1995 allowed many lab employees who already were performing or supervising moderate or high complexity tests to continue to do so based on their training and experience. 

 

Other important ways we have worked to reduce CLIA’s burden on providers include: 

• All routine inspections are scheduled ahead of time, rather than unannounced;
• Labs need not reapply for a new certificate for each 2-year survey cycle.  They need only confirm their status and note any changes they have made;
• Implementation of quality control and proficiency testing requirements was phased in over time and technical assistance provided, if needed; and,
• Labs may use existing systems or processes to meet CLIA requirements, such as using the patient chart to record test orders and results, and manufacturer’s instructions for a procedure manual.

 

FUTURE CLINICAL LABORATORY EFFORTS

Last summer Secretary Thompson created an Advisory Committee on Regulatory Reform, which includes patient advocates, providers, and other healthcare professionals from across the nation. This committee is helping to guide the Secretary’s efforts to streamline unnecessarily burdensome regulations and to eliminate inefficient regulations that interfere with the quality of health care for Americans.  We recognize that these requirements can have a disproportionate impact on small business providers who often do not have the resources that larger providers use to mitigate the effects of such burdens; and we believe that providers should focus on patients, not on paperwork.  This Advisory Committee has developed a number of recommendations to help make CLIA more user-friendly for small businesses and all providers, including some we plan to work on in the near future:

 

1. Simplify and clarify the CLIA requirements using plain language when possible to assist laboratory and POL staff in understanding and complying with guidelines.  We plan to include clarified and streamlined language in the final CLIA regulations that we hope to publish later this year.   Status:  Workgroups to develop user-friendly guidelines for compliance are already convened.  Input from POLs, professional and accreditation organizations, and experts will be solicited on these guidelines prior to publication.
2. Provide information to POLs about training opportunities by the State survey agencies and other accrediting bodies such as the College of American Pathologists and COLA to assist with interpretation and implementation of new CLIA requirements.   Status: COLA already has several educational programs available for laboratories to meet all categories of CLIA requirements.  We plan to work with all accrediting bodies to facilitate compliance following the publication of the final regulations.
3. Update the CLIA website, and develop a more user-friendly website with links to the Centers for Disease Control’s National Laboratory Training Network (NLTN).  Status: Discussions are underway with the NLTN, and our CLIA website, www.cms.gov/clia, is updated regularly with new policy and compliance information.
4. In the application package, include the CLIA requirements and a basic laboratory practices document in plain language tailored to the POLs test system menu for moderate complexity tests.  Status:  We are working with lab test manufacturers to develop a Basic Laboratory Practices document.  One is already used as part of the COW survey project.
5. Help laboratories interpret the CLIA requirements.  Status:  Through our contract with the State Agencies, we are always available to provide technical assistance or resources for laboratories, and we are considering other ways that we can help provide guidance. 
6. If compliance surveys are performed by CMS on waived laboratories, the evaluations should be according to CLIA guidelines and using criteria established in consultation with accrediting agencies and physician organizations.  Status:  We included feedback from many entities in the questionnaire for waived laboratory visits and we have just recently updated it again based on further comments, both internal and external.
7. Modify the Alternate Quality Assessment Survey (AQAS) self survey form, which includes questions about compliance with CLIA quality assurance requirements and is used to reward exceptionally good laboratories, as an educational tool to facilitate the survey and certification process.  Status:  Many individuals and organizations already use this form for training and understanding Quality Assessment concepts.  It is available on the CMS CLIA website at: www.cms.gov/clia.  We will also consider new ways that we can improve this form.
8. Increase the number of POL representatives serving on the Clinical Laboratory Improvements Advisory Committee (CLIAC), to more accurately reflect the number of POLs being regulated.  Status:  Many of the members of the current CLIAC have owned or operated POLs, and we will continue to look at ways we can ensure POLs are accurately represented.

 

The Committee also had some longer-term recommendations, including:

1. Offer training and simplified guidelines to assist laboratories with new CLIA requirements at meetings of laboratory professionals, accreditation bodies, and medical organizations.  Status:  CMS and CDC representatives are always available to speak and teach at organized professional, State, and regional meetings and do so quite frequently.  This is a valuable outreach tool that we will consider expanding.
2. Collaborate with the CDC on an educational brochure for POLs containing plain language interpretation of the regulatory requirements.  Status:  We have begun discussions with CDC.
3. Provide open forums with professional, medical, and accreditation laboratory organizations to solicit feedback on ways to improve outreach to POLs and to increase understanding of the CLIA program among physicians.  Status:  As mentioned, we always make CMS and CDC representatives available to attend various professional meetings, and we will consider expanding this outreach tool.
4. Solicit interest in developing an educational ”Clearinghouse” on the CLIA website that includes a multimedia educational program package.  Interested parties would include: CMS, other Federal agencies, professional, medical and laboratory accreditation organizations, and CLIAC.  Methods for evaluation of the effectiveness of educational programs should be designed.  Status:  A Clearinghouse of educational programs for laboratories is being compiled and includes information received from States, professional, and accreditation organizations.
5. Collaborate with States and private laboratory organizations to develop and promote self-assessment tools for laboratories, as well as other types of educational programs.  These should include an evaluation of effectiveness.  Status:  We plan to work with professional organizations to develop further self-assessment tools and we have already had one preliminary discussion.  We intend to develop mechanisms to measure education effectiveness as part of the plan.

 

While we have worked hard to streamline and simplify the administrative requirements of CLIA so that we can better ensure high quality care for all Americans, we know that we have more to do.  The Secretary’s Regulatory Reform Advisory Committee suggestions offer us a roadmap for further improvement.  We have a number of initiatives underway already, and have additional plans in development. 

 

CONCLUSION

With both ambulation assistance devices and clinical labs, our priority is ensuring the health and safety of Medicare beneficiaries.   We also are working hard to streamline our requirements and make Medicare a better business partner for all providers, including small businesses, because when these providers better understand and comply with Medicare regulations, they can spend more time caring for patients.  I appreciate this Committee’s continuing interest in the Medicare program, and I will continue to work with you as we improve further.  Thank you for inviting me to discuss these issues with you today.  I am happy to answer your questions.