Manage My Practice

Posts Tagged JCAHO

image_pdfimage_print

Laboratory Consultant Libby Knollmeyer: What is the Difference Between CLIA and COLA?

Posted by on February 2, 2011

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 a personnel 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.

Guest Author Libby Knollmeyer

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.

Tags: , , , , , , , , , , , , , , , , , , , , , , , ,

Posted in: Compliance, Day-to-Day Operations

Leave a Comment (2) →

The Benefits and Drawbacks of Managing a Private Practice vs. Managing a Hospital-Owned Practice

Posted by on December 5, 2010

The doctor's office on Transylvania Project, L...

Image via Wikipedia

Ownership

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

  1. 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.
  2. You are the top position in the practice, so you get to put your imprint on the practice.  You can often be more creative.
  3. Physicians can be very laid-back and practices can maintain a more relaxed, family-like atmosphere.
  4. 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!
  5. 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

  1. You report to the physicians who may not have business expertise and may fight you on your well-founded recommendations.
  2. There is no internal career path – you’re at the top in the practice.
  3. 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.
  4. 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.
  5. 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

  1. You report to a management professional who should understand the business and be supportive of your well-founded recommendations.
  2. 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.
  3. 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.
  4. You will get to interact with managers of other departments and broaden your hospital knowledge and understanding of the care continuum.
  5. 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

  1. 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.
  2. The entire system will be in a tizzy on a regular basis getting ready for a JCAHO (a.k.a. “The Joint Commission”) visit.
  3. 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.
  4. 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.
  5. 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?

Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Posted in: A Career in Practice Management, Physician Relations

Leave a Comment (3) →

Independent Diagnostic Testing Facilities (IDTFs) Can Expect Quarterly Letters From Medicare A/B MACs About January 2012 Accreditation Requirement

Posted by on July 8, 2010

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.

—————————————————————————————–

 

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.

CT Scan

Image via Wikipedia

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, 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.

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.)

This image shows a picture taken from a typica...

Image via Wikipedia

The letter will look like this:

[DATE]

[Supplier Name and Address]

Dear Physician/Non-Physician Practitioner/IDTF owner:

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.

MRI brain scan on Vimeo

Image by Jon Olav via Flickr

American College of Radiology (ACR)
1891 Preston White Drive
Reston, VA 20191-4326
1-800-770-0145

Intersocietal Accreditation Commission (IAC)
6021 University Boulevard, Suite 500
Ellicott City, MD 21043
1-800-838-2110

The Joint Commission (TJC)
Ambulatory Care Accreditation Program
One Renaissance Boulevard
Oakbrook Terrace, IL 60181
1-630-792-5286

If you have questions about this letter, contact [carrier or A/B MAC phone number/contact person].

Sincerely,

[Name of carrier or A/B MAC]

******************************************************************

Supplier Billed Advanced Medical Imaging CPT codes for Section 135 (a) of the MIPPA to Receive Accreditation Requirement Notification Letter

70336  70540  71250  72125  73200  74150
70450  70542  71260  72126  73201  74160
70460  70543  71270  72127  73202  74170
70470  70544  71275  72128  73206  74175
70480  70545  71550  72129  73218  74181
70481  70546  71551  72130  73219  74182
70482  70547  71552  72131  73220  74183
70486  70548  71555  72132  73221  74185
70487  70549    72133  73222
70488  70551    72141  73223
70490  70552    72142  73225
70491  70553    72146  73700
70492  70554    72147  73701
70496  70555    72148  73702
70498  70557    72149  73706

70558    72156  73718

70559    72157  7371972158  73720
72159  73721
72191  73722
72192  73723
72193  73725
72194
72195
72196
72197
72198
72200
75557  76360  77011  78000  78811
75559  76376  77012  78001  78812
75561  76377  77021  78003  78813
75563  76380  77058  78006  78814
76390  77059  78007  78815
76497  77078  78010  78816
76498  77079  78011  78891
78015
78016
78018
78020
78070
78075
78099

Enhanced by Zemanta

Tags: , , , , , , , , , , , , , , , , , , , , , , , , , ,

Posted in: Compliance, Headlines, Medicare & Reimbursement

Leave a Comment (7) →