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.
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.
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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:
”¢ Diagnostic magnetic resonance imaging (MRI),
”¢ Computed tomography (CT), and
”¢ 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.
CMS held a two-hour Open Door Forum today and there was so much good information shared that I thought I’d pass my notes from the call along to you.
New EFT Form
The revised EFT (Electronic Funds Transfer) authorization form 588 is available here (pdf.) The old form will still work for a few months longer before it becomes invalid.
Changes to the Medicare Program Integrity Manual
The Program Integrity Manual (publication 100-08) will have revisions related to the changes in provider enrollment. The online-only manual here will have content moved from Chapter 10 to Chapter 15 and the provider enrollment information will be easier to understand. 🙂
The Question on Everyone’s Lips
How do I know if I’m listed in PECOS (Provider Enrollment and Chain/Ownership System) and how do I know if others are listed in PECOS? A new downloadable file is now available here (12,000 pages!) and everyone listed in this Ordering/Referring file has approved enrollment status. Anyone not appearing on this list is not in approved status, or has opted completely out of the Medicare program.
Advanced Diagnostic Imaging
Beginning in January 2012, all diagnostic magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine imaging such as positron emission tomography (PET) must be performed in a facility accredited by the American College of Radiology (ACR), The Joint Commission (TJC) or the Intersocietal Accreditation Commission (IAC) for the technical component of the test to be reimbursed by Medicare. This rule does not apply to x-rays, ultrasound, fluoroscopy, mammography or DEXA scans and does not apply to any professional component.
Hospitals not enrolled in PECOS or not receiving EFT (Electronic Funds Transfer) will be contacted by CMS in an attempt to get all hospitals revalidated.
PECOS (pronounced “pay-cose”)
CMS recommends that anyone with questions or just getting started in PECOS read the “Getting Started Guide”, of which there are two versions, both available here in pdf form. One is for providers and one is for suppliers of DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.) You need to know your corporate structure before getting started because the business must enroll before the providers can assign benefits to the business. The 855I is for individual/solos providers and the 855B is for non-individuals (multiple owners) billing Medicare Part B and assigning benefits to a legal entity/corporation. Dentists and pediatricians who order or refer services for Medicare patients are required to have an enrollment record in the PECOS. Residents and interns are exempt from the enrollment requirement, but an attending physician needs to be identified on the claim when a service is ordered or referred. The main page for enrollment is https://www.cms.gov/MedicareProviderSupEnroll/
Two Ways to Get Into PECOS
One is to complete the paper form in BLUE INK (and if time is of the essence CMS suggests that you use the paper form) and let the MAC enter it into PECOS for you. The other is to use the internet-PECOS system directly, and sign, date and mail the certification statement to complete the process. Submit the participation form or EFT form if required. The certification form for the paper process is NOT the same as the certification from for the internet-PECOS process.
What is the 30-day rule?
The 30-day rule states that you can bill for services provided to Medicare patients up to 30 days prior to your filing date. The filing date is the date your enrollment is accepted, not the date you mailed it. Online it will say “Status Approved”, and you will receive an email, and then a letter confirming it. You will appear on the Ordering/Referring file on the CMS website.
What happens to payments for patients that were referred by a provider not enrolled on PECOS?
Even though you are enrolled, if the referring physician is not enrolled, you will not be paid for that patient’s services. However, if that referrer becomes enrolled, you can resubmit the claim and it will be paid.
What happens on July 6, 2010? When does this happen?
July 6, 2010 The compliance date for Part A providers (hospitals, skilled nursing homes and home health agencies) and Part B providers (physicians, ambulance) must be enrolled in PECOS as ordering/referring physicians for payments to be made has been delayed indefinitely!
What happens on July 13, 2010?
DMEPOS (pronounced “demmy-pos”) providers must be enrolled in PECOS to receive Medicare payments.
What should be done if a provider leaves a group?
The provider or his Authorized Official (CEO, CFO, Manager) should file a 855R or make the change in PECOS as soon as possible.
Why do provider offices still request UPINs from our office?
Unclear. UPINs were no longer required as of May 23, 2008. The NPI is the only number accepted on Medicare claims.
Should the information submitted on a 855 be the same information in PECOS?
Yes, if it isn’t, contact the Help Desk. Their toll-free number is 1-866-484-8049 and their e-mail address is firstname.lastname@example.org.
For more information on the nuts and bolts of PECOS, see my post here.