CEO SUMMARY: Last year, the Centers for Medicare and Medicaid Services (CMS) used publication of the proposed 2011 Medicare Physician Fee Schedule to introduce new language that would require, as of January 1, 2011, that all paper requisitions for clinical laboratory tests for Medicare patients be signed by a physician or qualified non-physician provider. Public comment was generally critical of the new rule and CMS announced that it would delay compliance with the new rule until the second quarter of 2011.
IT WAS WELCOME NEWS LAST MONTH when clinical laboratories learned that the Medicare program would delay, for 90 days, enforcement of the final rule requiring that physician’s signatures be on all paper requisitions for clinical laboratory tests involving Medicare patients. The new rule was scheduled to take effect on January 1, 2011.
However, in seeking to implement the new rule, the federal Centers for Medicare and Medicaid Services (CMS) may have a bigger fight on its hands than it expected. Clinical laboratory and pathology associations are coming together to oppose imposition by CMS of the requirement that a paper requisition for clinical lab tests must have a physician signature.
There is a good reason for this opposition. Just nine years ago, a broad coalition of laboratory and healthcare organizations negotiated with CMS on a wide range of issues. One of these issues was the requirement that a physician signature be on paper requisitions for clinical laboratory tests.
Under a mandate that was part of the Balanced Budget Act of 1997 (BBA), CMS convened a Negotiated Rulemaking Committee. Participating in the Negotiated Rulemaking Committee were 18 organizations made up of laboratory and healthcare stakeholders, including the American Medical Association (AMA) and the Medical Group Management Association (MGMA). This committee met at least nine times with CMS during 2000.
As a result of these meetings—which required unanimous decisions, CMS (then known as HCFA—the Healthcare Financing Administration) agreed with the consensus of the Negotiated Rulemaking Committee that a physician signature would not be required on a paper requisition for a clinical laboratory test.
In its final rule, dated November 23, 2001, and published in the Federal Register as 66 FR 58788, CMS did not require a physician’s signature on a paper requisition for a clinical laboratory test. CMS did provide guidance that “documentation that the physician ordered the test must be available upon our request.”
Thus, just nine years later, Medicare officials apparently decided to ignore the input and the decisions made with the Negotiated Rulemaking Committee during 2000 that directly led to the final rule published in the Federal Register on November 23, 2001. That rule did not require a physician signature on a paper requisition for clinical laboratory tests.
These points were emphasized in a letter to CMS Deputy Administrator Marilyn Tavenner. The letter was dated December 3, 2010, and was signed by 29 laboratory and healthcare organizations. The letter stated “…we strongly urge you to delay implementation of this provision by at least one year, until January 1, 2012, allowing for adequate time for all involved parties to discuss the implications of this requirement and clarify the myriad issues surrounding implementation, such as the role of the clinical laboratory in ensuring compliance.”
Delay in Enforcement
The new rule was scheduled to take effect on January 1, 2011. However, as noted above, the Centers for Medicare and Medicaid Services announced on December 21, 2010, that it would delay enforcement of this new rule until after the first quarter of 2011.
In the statement posted on its website, CMS explained that it “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.”
CMS Posts Statements
Laboratory professionals involved in lobbying CMS on this issue report that CMS officials have not provided a convincing public explanation for their need to change a policy that has functioned smoothly in the nine years since the 2001 final rule was published.
It appears that, at different times, CMS has offered three reasons for this rule change. One reason given was that this rule would encourage adoption of electronic test orders. That certainly is not a benefit that will be offset by the turmoil that enforcement of the final rule will cause for referring physicians and laboratories.
CMS officials gave a second reason: the signature requirement rule will reduce Medicare fraud and abuse and better protect the integrity of the Medicare program. However, federal officials do not provide any convincing evidence that a policy that has worked over the past nine years directly encourages forms of fraud and abuse that the new rule would prevent. As well, the existing rule does require documentation of the need for the test to be available upon request by a carrier.
A third reason is to make the paper requisition signature requirement consistent with the requirement for other physician orders. Since the current system has worked well for providers, for labs, and for Medicare carriers for nine years, this reason may simply represent the bureaucrats’ need for order—regardless of the disruption it causes to the honest citizens being regulated.
Few lab managers remember the Negotiated Rulemaking Committee of 2000. Yet those events are directly relevant to the current actions being taken by CMS.