Home 5 Clinical Diagnostics Insider 5 Medical Necessity Requirement Bites Anatomic Pathologists

By Robert Mazer  bio The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains… . . . read more

By Robert Mazer  bio

The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains.

Medicare permits a pathologist to order special stains when they are medically necessary and other requirements are satisfied. Nevertheless, special stains have come under significant scrutiny over recent years.

Use of special stains before review of routine hematoxylin and eosin (“H & E”) stains has received particular attention. CAP has argued that this should be a matter of medical judgment.

A recent settlement indicates that DOJ may disagree, requiring a North Carolina pathology group to pay approximately $600,000 to settle False Claims Act allegations for billing allegedly unnecessary special stains.

In its related press release, DOJ stated: “The government considers use of special stains before the analysis of the routine H & E stained specimen to be medically unnecessary.”


Pathologists would be smart to review current practices, as it’s doubtful that we’ve seen the last of this type of case.

As part of a separate settlement, DOJ required payment of approximately $900,000 to settle claims based on the promotion of a stain as being able to definitively diagnose a particular condition, and submission of related claims, when the test’s promotion violated FDA requirements and was not adequately supported by scientific evidence.


Robert Mazer Bio:

I am a Shareholder with Baker Donelson experienced in assisting acute care and critical access hospitals, clinical laboratories and other health care providers with third-party payment, compliance and regulatory issues. I help clients develop business strategies that are practical, will accomplish their legitimate business objectives, and will comply with relevant laws and regulations. This includes laboratory discount, lab to lab referral, and other billing arrangements.

I assist providers involved in disputes related to third-party payments and regulatory compliance, including overpayment demands based on medical necessity determinations. I have extensive experience before the Provider Reimbursement Review Board, most recently related to CAH claims for home office costs, and in challenging sanctions under the Clinical Laboratory Improvement Amendments, particularly related to alleged proficiency testing referrals. My efforts have resulted in favorable settlements and ground breaking victories.

It’s my experience that a good collaborative arrangement between client and attorney leads to the best possible result. I bring to bear extensive knowledge and experience regarding industry practices and legal and regulatory authorities. I also understand financial issues, and may be the only practicing attorney to have served on the AICPA health care committee.

I also organize and participate in the Laboratory Immersion Session at the HCCA Compliance Institute.

Practice Focus:

  • Assisting hospitals, clinical laboratories and other health care providers with payment, compliance and regulatory issues.
  • Working to help providers obtain (or keep) Medicare and other third-party payments for services provided.

When not working, I’m spending time with my wife and goldendoodle, playing tennis (badly), enjoying portrait photography or growing Japanese Maples.

Editor’s picks:

From – National Intelligence Report
DOJ Surveys False Claims Victories for 2016

From – G2 Compliance Advisor
Penalties for False Claims Aren’t the Only FCA Risk to Avoid

From – Laboratory Industry Report
False Claims Act Cases Continue to Be a Cash Cow for the Feds

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