Medicare Program Won’t Enforce the New Rule For At Least 90 Days

Yesterday brought welcome news for all clinical laboratories and pathology group practices in the United States. That’s because the Centers for Medicare and Medicaid Services (CMS) posted an announcement on its website that it would delay enforcement of the final rule requiring that physician’s signatures be on all paper requisitions for Medicare patients starting January 1, 2011. This includes laboratory test requisitions.

This rule was part of the Final Medicare Physician Fee Schedule Rule published in the Federal Register on November 29, 2010. In short, once enacted, the rule will require all paper requisitions sent to Medicare to have a doctor’s signature to be reimbursed.

Since that time, many hospitals, physicians, non-physician providers (NPP) and clinical diagnostic laboratories have spoken out against this rule, noting that it is unworkable and unmanageable. In addition, there has been significant confusion concerning electronic requisitions, and what constitutes an electronic signature.

In response to the public comments, CMS announced that electronic requisitions would not require doctor’s signatures to be reimbursed. This announcement only deepened the confusion, since Medicare will soon penalize doctors who submit non-electronic claims.

A Bit of Medicare Déjà vu for Medical Laboratories

It was obvious to pathologists and clinical laboratory managers that the new CMS rule would be an unworkable requirement. It was in the late 1990s when Medicare required laboratory test claims for Medicare patients to include ICD-9 codes. It has been a continuous struggle for clinical labs and pathology groups to get the referring doctors to comply with the requirement, so that Medicare will reimburse the laboratory appropriately for the tests it performed.

That is the reason why the CMS requirement that a doctor have a signature on a paper requisition was viewed with concern, since medical laboratories have a legal obligation to perform a test requested by a physician. However, if the laboratory submits the claim to Medicare, and the paper test requisition was not signed by the referring physician, then Medicare would not reimburse that claim.

Clinical Laboratory Organizations Speak Out

The American Clinical Laboratory Association (ACLA), along with several other organizations representing large blocks of the healthcare industry, met with CMS representatives as far back as March 2010. Their goal was to impress upon CMS the severity of the results in the event that the government agency was to go ahead and fully implement the signature requirement. In a press release issued yesterday, ACLA stated that the rule “would have resulted in a crisis in access to laboratory services for the nation’s seniors. ACLA maintains that the policy is unworkable, and is committed to working with CMS to examine feasible alternative approaches to meet CMS’ objective of ensuring that laboratory requisitions are appropriately documented.

“A rule adopted by CMS in 2000 established the policy that there are alternatives to physicians signing laboratory requisitions. This policy was reiterated in numerous communications from CMS as recently as March 2010. In a surprising turnabout in this policy, the 2011 proposed Medicare Physician Fee Schedule Rule, released in July 2010, required a physician signature on all requisition forms reimbursed under the Clinical Laboratory Fee Schedule. In spite of comments from all stakeholders—including laboratories, hospitals, physicians, nursing homes and others—opposing this requirement in the proposed rule, the final rule contained the same requirement,” ACLA explained.

“Immediate implementation of the requirement would have had disastrous consequences for patients and providers,” said ACLA President Alan Mertz in the press release. “The delay provides an essential opportunity to work with CMS on a plausible alternative policy that addresses CMS’ goals while avoiding severe disruption in providing critically important laboratory services for Medicare beneficiaries.”

CMS officially announced the delay on their website. The announcement states that “In the November 29, 2010 Medicare Physician Fee Schedule final rule, the Centers for Medicare and Medicaid Services (CMS) finalized its proposed policy to require a physician’s or qualified non-physician practitioner’s (NPP) signature on requisitions for clinical diagnostic laboratory tests paid under the clinical laboratory fee schedule effective January 1, 2011. A requisition is the actual paperwork, such as a form, which is provided to a clinical diagnostic laboratory that identifies the test or tests to be performed for a patient.

“Although many physicians, NPPs, and clinical diagnostic laboratories may be aware of, and are able to comply with, this policy, CMS is concerned that some physicians, NPPs, and clinical diagnostic laboratories are not aware of, or do not understand, this policy. As such, CMS will focus in the first calendar quarter of 2011 on developing educational and outreach materials to educate those affected by this policy. As they become available, we will post this information on our website and use the other channels we have to communicate with providers to ensure this information is widely distributed. Once our first quarter of 2011 educational campaign is fully underway, CMS will expect requisitions to be signed.”

Clinical Laboratories Should Prepare to Comply With the New Rule

The Clinical Laboratory Management Association (CLMA) on their website urges labs to use this delay to their advantage.

“Laboratories should prepare accordingly by educating their clients about the rule and starting to track and collect data on how many they are getting without signatures and who they are coming from. As difficult a process as this will be the best outcome will be the result of a focused strategic effort part of which will be working with data that allows the laboratory to identify noncompliant physicians so they can target their education efforts on those physicians rather than harass the physicians you are complying.”

Related Information:

CMS Announcement: Signatures on Requisitions for Clinical Diagnostic Laboratory Tests

CMS Delays Enforcement of Medicare Physician Signature Requirement Three Months

Physician Signatures on Laboratory Requisitions

The Official Web Site for the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs

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