Prior to CLIA ’88 (Clinical Laboratory Improvement Amendments of 1988) only laboratories participating in interstate commerce underwent inspections. Since the enactment of CLIA ’88, all laboratories are subject to inspection, and all non-waived laboratories are inspected. CLIA has the right to appear at any point in time to inspect a lab.
There are two types of inspections for non-waived labs: routine and non-routine
Routine inspections take place every two years as mandated by CLIA, regardless of which agency is responsible for the inspection. If a lab has a Certificate of Compliance, CLIA will be the inspecting agency. If the laboratory has opted for a Certificate of Accreditation from one of the approved accrediting agencies, that agency will perform the inspection. Either way, the inspections are set on a two year cycle and the renewal of the laboratory’s certificate is dependent upon successful completion of the inspection. If no deficiencies are cited, the certificate will be renewed very soon after the inspection is completed. If deficiencies are cited during the inspection, the laboratory will receive a deficiency report and will be given a timeline to submit a plan of correction. Once the plan of correction is accepted by the inspecting agency, the certificate will be renewed. Failure to achieve a successful conclusion to the inspection process will result in the cancellation of the lab’s certificate, and therefore loss of privileges to do lab testing and to bill for lab testing.
The inspection cycle differs slightly for a newly set-up laboratory. CLIA or the accrediting agency will come in to do an inspection after the lab has been in operation for 3 – 6 months to ensure everything required is in place and all regulations are being followed. CLIA and the accrediting agencies do not inspect prior to the lab starting testing operations because they want the lab to generate data for them to review upon their inspection.
If you are a physician, non-physician practitioner or Independent Diagnostic Testing Facility (IDTF) who supplies imaging services and submits claims for the Technical Component (TC) of Advanced Diagnostic Imaging (ADI) procedures to Medicare contractors (carriers and A/B Medicare Administrative Contractors (MACs)), you should know that you must be accredited by Sunday, January 1, 2012. If your facility uses an accredited mobile facility, and you bill for the TC of ADI, you must also be accredited. The accreditation requirement is attached to the biller of the services.
Those not accredited by that deadline will not be able to bill Medicare until they become accredited.
For those planning on seeking accreditation to continue performing the technical component of ADI services, know that accreditation is dependent on the demonstration of quality standards, including (but not limited to):
Qualifications and responsibilities of medical directors and supervising physicians;
Qualifications of medical personnel who are not physicians;
Procedures to ensure that equipment used meets performance specifications;
Procedures to ensure the safety of beneficiaries;
Procedures to ensure the safety of person who furnish the imaging; and
Establishment and maintenance of a quality assurance and quality control program to ensure the reliability, clarity and accuracy of the technical quality of the image.
Additionally, the accreditation process may include:
CMS will host a national provider call on the upcoming mandatory accreditation program for all suppliers that furnish the technical component of advanced diagnostic imaging on Thursday, June 23, 2011 from 2:30 – 4:00 p.m. EST. Subject matter experts will discuss what the requirements are to meet the Sunday, January 1, 2012, deadline; who these requirements effect; and how to become accredited. CMS will update information previously discussed on Open Door Forums that will streamline the requirements. See my original post on this topic here.
The target audience for this call includes physician office staff and all Medicare fee-for-service providers; the agenda will include:
CLIA (Clinical Laboratory Improvement Amendments of ’88) is the basic set of regulations governing all laboratories that test human specimens (with rare exceptions). It is the minimum standard for labs.
CLIA has given “deemed status” to several other agencies allowing them to accredit labs and inspect the labs in CLIA’s stead. COLA is one of these agencies (as are CAP and The Joint Commission). All accrediting agencies must be at least as strict as CLIA, or to phrase it a different way, all accrediting agencies must have the same regulations as CLIA does, and then may add additional regulations on top of the CLIA regulations if they wish.
There is little difference between CLIA and COLA from a regulatory viewpoint. COLA enforces a few more requirements than CLIA does, but the differences are relatively minor. One example is that COLA requires correlation studies be done when a new instrument is installed to compare the new instrument to an old instrument or a reference lab method and CLIA does not. Another is that CLIA requires an overlap of old control lot numbers to new control lot numbers but doesn’t specify a number of times they must be run together; COLA requires overlapping old and new 5 times. So there are differences, but it is pretty easy to see that the differences in regulations are not extreme. CLIA publishes their Interpretive Guidelines on the Internet for all to read so you have ready access to the information as to how a regulation is going to be applied; COLA does not and will not share their Interpretive Guidelines (they consider it proprietary information), so understanding how a questionable regulation will be applied is left to a guess or a phone call to COLA headquarters in Maryland.
From apersonnel standpoint, there is no difference between CLIA and COLA. COLA follows the CLIA requirements for personnel qualifications and responsibilities, both for moderately complex labs and for highly complex labs.
From an inspection standpoint, there can be notable differences, depending on the state in which the lab is located. CLIA is a federal program but is administered at the state level in each state. While the regulations they enforce are the same, the quality of the CLIA departments from one state to another varies widely. COLA is a nationwide program and the inspectors move freely between states as needed to inspect labs. Both agencies train their inspectors, so in a perfect world all inspections would be the same within an agency. Unfortunately, however, that is not the real life situation. The quality of the inspectors and the inspections they perform can vary widely ”“ in each agency. In many states, CLIA is short-staffed so delays are common. On the whole, COLA is probably a little more uniform throughout the country than CLIA is, but CLIA is usually more dependable with post-inspection routine and follow-up than COLA.
The costs associated with CLIA and COLA are pretty much the same. Both base their costs on the number of non-waived tests performed in a year’s time. All labs pay CLIA a Certificate Fee””the cost of renewing the CLIA identification number. And all non-waived labs pay a Compliance Fee to cover the cost of their inspection, but the Compliance Fee is billed by the inspecting agency, so if you’re inspected by CLIA the Compliance Fee will be billed by CLIA and if you are accredited by COLA, the COLA fee covers the cost of the inspection.
Several states have state lab regulations on top of CLIA regulations that are enforced. Pennsylvania, New York, Massachusetts, Maryland, Illinois, and California are several examples. Whenever there is state licensure of labs in addition to CLIA licensure, the fees will usually be higher because there will be both a CLIA and a state fee. If your lab is located in a state with additional state regulations, be sure and find out how the state regulations differ from CLIA and/or COLA (depending on which you choose for compliance). And be aware that when CLIA amends a regulation to make it less strict, COLA and/or the state may not follow suit. Also be aware that if your lab fails to maintain accreditation with one of the agencies other than CLIA, they will lose their CLIA Certificate as well unless they can pass a CLIA inspection. The accrediting agencies carry just as much weight as does CLIA.
Whenever I am asked which agency I recommend for a new lab, my answer is “it depends”¦” In some states, CLIA is absolutely the best choice (North Carolina is one of those states) because the department is very well run and the inspectors are very well trained and highly accessible when assistance is needed. In other states, CLIA is a disaster and COLA is absolutely the best choice (California and Louisiana being two examples). In the great majority of states, it really doesn’t matter which agency is chosen because overall they both do excellent jobs.
Consultant Elizabeth Knollmeyer, B.S., MT (ASCP) has over 40 years experience in the laboratory industry. She specializes in financial, operational management and compliance issues for both hospital and physician office laboratories. Libby has a wide variety of experience with her areas of special expertise including financial review and management, Quality Management protocols, Outreach development, compliance and regulatory assistance, lab design and up fitting, lab remodeling, and market research for IVD manufacturers. She works independently and with large consulting groups to provide interim management for hospitals, and serves as adviser to lab equipment and supply distributors. She can be reached at (336) 288-5823 or at eknollmeyer@triad.rr.com.
Private practices are organized in a corporate model where the physicians are shareholders, or where one or more physicians own the practice and employ other physicians or providers. Private practices are almost exclusively for-profit. Physician practices are organized into corporations for the tax benefits as well as protecting the owners from liability judgments.
Hospitals can be for-profit, not-for-profit or government-owned. For-profit hospitals make up less than 20% of the total hospitals in the United States.
Financial Models
Private practice owners take a salary draw, split any receipts after all expenses are paid, and generally distribute receipts monthly or quarterly. This leaves very little at year end to be taxed through the corporation.
Hospitals that employ physicians typically guarantee a salary and offer an incentive plan where the physicians earn more for seeing more patients and/or being more productive based on work Relative Value Units (wRVUs). Hospitals may or may not use a practice expense and revenue model to measure the margin.
Benefits of Managing a Private Practice
You get to do everything, so if you like or want to learn about HR, marketing, finance, IT, contract negotiation, revenue cycle management, facility management, and lots of other stuff, you’ll get to do it in a private practice.
You are the top position in the practice, so you get to put your imprint on the practice. You can often be more creative.
Physicians can be very laid-back and practices can maintain a more relaxed, family-like atmosphere.
Decision-making can be straightforward and swift, so you can help your practice to be nimble in response to news events, trends and new ideas. If your practice decides to become a concierge practice or stop or start taking a particular payer, so be it!
You may find it easier to get a foot in the door and start your management career in a private practice as physicians don’t always hire managers using traditional means. A recommendation from another manager, a consultant or a physician may be enough to get you started.
Drawbacks of Managing a Private Practice
You report to the physicians who may not have business expertise and may fight you on your well-founded recommendations.
There is no internal career path – you’re at the top in the practice.
Physicians will make less money every time a new non-revenue generating position is added or any time equipment needs to be replaced – expect them to be generally slow to respond to capital expenditure needs, especially if they cannot see that any new revenue will come from the expense.
When physicians “eat what they kill”, taking home the dollars they personally earn less their expenses, they can be pitted against each other and have conflicting priorities.
Your practice could be purchased by a hospital and you could find yourself out of a job, or your job radically changed.
Benefits of Managing a Hospital-Owned Practice
You report to a management professional who should understand the business and be supportive of your well-founded recommendations.
You will receive support from other hospital departments: the Human Resources department will screen, orient and provide benefit support to your staff; the Information Systems department will provide and maintain your practice management system, EMR system and other hardware and software; and the Accounting department will pay the bills and write the payroll.
You may be able to climb the career ladder and manage multiple practices, or become the Vice President of Physician Practices, or the COO, CFO or CEO of the hospital.
You will get to interact with managers of other departments and broaden your hospital knowledge and understanding of the care continuum.
You can learn a lot from the process of preparing for and living through a JCAHO (a.k.a. “The Joint Commission”) visit.
Drawbacks of Managing a Hospital-Owned Practice
Hospitals use different terminology for charges, adjustments and receipts and work on the accrual system instead of the cash system, which most private practices use. It takes time to understand and distinguishes the terminology and process differences.
The entire system will be in a tizzy on a regular basis getting ready for a JCAHO (a.k.a. “The Joint Commission”) visit.
You can expect to have much less autonomy in a hospital system and there may be more red tape involved in getting even simple requests filled.
Hospital administration may find it difficult to relate to the perspective of the hourly staff and it could be frustrating to balance the needs of the staff and the needs of the organization.
Because the hospital is the big-dollar earner, the needs of the clinics may be second, third or fourth down the line in importance.
What do you see as the benefits or drawbacks of your private practice or hospital practice job?
For more information on the Medicare accreditation requirement for entities billing the technical component for advanced diagnostic imaging (CT, MRI, PET/Nuclear Medicine) effective January 1, 2012, read my post here.
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Medicare Learning Network (MLN) just released MM6912, effective August 2, 2010: Mailing To All Individual Practitioners, Medical Groups and Clinics and Independent Diagnostic Testing Facilities (IDTF) Who Are Billing or Have Billed For The Technical Component of Advanced Diagnostic Imaging Services
What exactly is an IDTF?
Some suppliers that perform diagnostic tests, other than clinical laboratory or pathology tests, are required to enroll with Medicare as an Independent Diagnostic Testing Facility (IDTF). Not all suppliers that perform these diagnostic tests are required to enroll as an IDTF. Generally, entities can bill for the technical component of the diagnostic tests without an IDTF enrollment if it has the following characteristics:
A physician practice that is owned, directly or indirectly, by one or more physicians or by a hospital
A facility that primarily bills for physician services and not for diagnostic tests
A facility that furnishes diagnostic tests primarily to patients whose medical conditions are being treated or managed on an ongoing basis by one or more physicians in the practice
The diagnostic tests are performed and interpreted at the same location where the practice physicians also treat patients for their medical conditions
If a substantial portion of the facility’s business involves the performance of diagnostic tests, the diagnostic testing services may be a sufficient separate business to require enrollment as an IDTF. In that case, the physician or physician group practice can continue to be enrolled as a physician or physician group practice but are also required to enroll as an IDTF. The physician or group can bill for professional fees and the diagnostic tests they perform on their patients using their billing number. Therefore, the practice must bill as an IDTF for diagnostic tests furnished to Medicare beneficiaries who are not regular patients of the physician or group practice.
Who will receive a mailing?
Enrolled physicians, non-physician practitioners, including single and multi- specialty clinics, and IDTFs who have billed the Medicare program for the technical component of advanced diagnostic testing services within the preceding six month period and who continue to have Medicare billing privileges with Medicare contractors (carriers and Part A/B Medicare Administrative Contractors (A/B MACs)) are affected.
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If you have billed the Medicare program for the technical component of advanced diagnostic testing services within the preceding six month period and continue to have Medicare billing privileges with Medicare contractors, you will receive a letter from your Medicare contractor advising you of the need to become accredited by January 1, 2012, in order to continue to provide these services and bill Medicare.
When more than one physician or non-physician practitioner is operating within a group, such as a single specialty or multispecialty clinic, only the group will receive the letter, not each of the individual physicians or non-physician practitioners working for the group.
What will the mailing say?
You must be accredited by one of the three Centers for Medicare & Medicaid
Services (CMS) approved national accreditation organizations by January 1, 2012,
in order to be eligible to continue to furnish the technical component of advanced
diagnostic testing services to Medicare beneficiaries and submit claims for those
services to your Medicare contractor.
Your contractor will be mailing the letter quarterly beginning with July 2010 through July 2011. If necessary, follow the instructions in the letter to become accredited by January 1, 2012, in order to continue billing for the technical component of advance diagnostic imaging services. Make sure that your office staffs are aware of these new accreditation requirements and begin the accreditation process as soon as possible to protect your Medicare billing rights for these services.
Why do IDTFs have to become accredited now?
Section 135(a) of the Medicare Improvements for Patients and Providers Act of
2008 (MIPPA) amended section 1834(e) of the Social Security Act and required
the Secretary, Health and Human Services, to designate organizations to accredit
suppliers, including but not limited to physicians, non-physician practitioners and
Independent Diagnostic Testing Facilities, that furnish the technical component
(TC) of advanced diagnostic imaging services.
What qualifies as an advanced diagnostic imaging procedure?
MIPPA specifically defines advanced diagnostic imaging procedures as including:
Ӣ Diagnostic magnetic resonance imaging (MRI),
Ӣ Computed tomography (CT), and
Ӣ Nuclear medicine imaging, such as positron emission tomography (PET).
MIPPA expressly excludes from the accreditation requirement x-ray, ultrasound,
and fluoroscopy procedures. The law also excludes from the CMS accreditation
requirement diagnostic and screening mammography, which are subject to quality oversight by the Food and Drug Administration under the Mammography Quality Standards Act.
How long does it take to become accredited?
Since CMS expects that it may take as much as nine months from the time you initiate the accreditation process to completion, you should begin the accreditation process for advanced diagnostic imaging services as soon as possible, but not later than March 2011.
Who are the accrediting organizations?
CMS approved three national accreditation organizations — the American College
of Radiology, theIntersocietal Accreditation Commission, and The Joint
Commission — to provide accreditation services for suppliers of the TC of advanced diagnostic imaging procedures. The accreditation will apply only to
the suppliers of the images themselves, and not to the physician interpreting
the image. All accreditation organizations have quality standards that address the safety of the equipment as well as the safety of the patients and staff.
If you have questions, contact your Medicare carrier and/or A/B MAC at
their toll-free number, which may be found here (zip file.)
In accordance with Section 135(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), suppliers, including but not limited to physicians, non-physician practitioners and Independent Diagnostic Testing Facilities that furnish the technical component (TC) of advanced diagnostic imaging services must be accredited by January 1, 2012 in order to continue to furnish these services to Medicare beneficiaries.
Our records indicate that you have furnished advanced diagnostic imaging procedures such as diagnostic magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine imaging such as positron emission tomography (PET) within the last six months. If you are not accredited by one of the organizations shown below by January 1, 2012, you will not be eligible to bill the Medicare program for advanced diagnostic imaging services. This letter requests that you take the necessary action to become accredited by the January 1, 2012 deadline. Since we expect it can take up to nine months from the time you initiate the accreditation process to completion, we urge you to begin the accreditation process for advanced diagnostic imaging services as soon as possible.
MIPPA expressly excludes from the accreditation requirement x-ray, ultrasound, and fluoroscopy procedures. The law also excludes from the CMS accreditation requirement diagnostic and screening mammography which are already subject to quality oversight by the Food and Drug Administration under the Mammography Quality Standards Act.
The Centers for Medicare & Medicaid Services (CMS) approved three national accreditation organizations ”“ the American College of Radiology, the Intersocietal Accreditation Commission, and The Joint Commission – to provide accreditation services for suppliers of the TC of advanced diagnostic imaging procedures. The accreditation will apply only to the suppliers of the images themselves, and not to the physician interpreting the image. All accreditation organizations have quality standards that address the safety of the equipment as well as the safety of the patients and staff. The accrediting organization that issues your accreditation will notify Medicare once your accreditation is complete and approved.
To obtain additional information about the accreditation process, please contact the accreditation organizations shown below.
