Four Regulatory Developments Coming This Fall That Are Relevant for Clinical Laboratory Leaders and Pathology Group Managers
Regulators and lawmakers are considering proposed changes to CLIA and PAMA involving medical laboratory services
Clinical laboratories and pathology groups should monitor a series of federal regulatory developments underway this fall. The proposals and documents will potentially affect how lab managers and staff do their jobs and how much Medicare reimbursement medical laboratories receive for certain diagnostic tests next year.
Among the initiatives under consideration are the following:
- Proposed changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Protecting Access to Medicare Act of 2014 (PAMA).
- New guidance on telemedicine fraud.
- Pending bills in Congress that would change the regulation of laboratory-developed tests (LDTs).
Below are details about these laboratory-related federal bills and regulatory documents that observant laboratory managers will want to track in the coming months.
CLIA Fee Increases and Testing Personnel Changes
The federal Centers for Medicare and Medicaid Services (CMS) is examining fee and personnel changes for CLIA. Officials from CMS are reviewing public comments on the proposal ahead of publishing a final rule.
Among other changes, the proposal would:
- Institute a 20% across-the-board increase on existing fees.
- Establish a biennial increase of CLIA fees for follow-up surveys, substantiated complaint surveys, and revised certificates.
- Add doctoral, master’s, and bachelor’s degrees in nursing to qualify testing personnel for high and moderate complexity testing.
As The Dark Report noted in “Clinical Laboratories Face 20% Increase in CLIA Fees,” opposition to the new nurse qualifications is coming from the American Hospital Association (AHA) and other groups. (If you are not a subscriber to The Dark Report, you can start a free trial by clicking here.)
Seven Characteristics of Potential Telemedicine Fraud That Affect Clinical Laboratories
In July, on the heels of federal prosecutors indicting 13 defendants for alleged genetic testing and telemedicine fraud, the US Department of Health and Human Services Office of Inspector General (OIG) issued a warning about telemedicine fraud.
The Special Fraud Alert, “OIG Alerts Practitioners to Exercise Caution When Entering into Arrangements with Purported Telemedicine Companies,” outlines seven “suspect characteristics” of telemedicine that might point to fraudulent Medicare billing.
The characteristics include:
- “The Practitioner does not have sufficient contact with or information from the purported patient to meaningfully assess the medical necessity of the items or services ordered or prescribed.
- “The Telemedicine Company compensates the Practitioner based on the volume of items or services ordered or prescribed, which may be characterized to the Practitioner as compensation based on the number of purported medical records that the Practitioner reviewed.
- “The Telemedicine Company only furnishes items and services to Federal health care program beneficiaries and does not accept insurance from any other payor.
- “The Telemedicine Company does not expect Practitioners (or another Practitioner) to follow up with purported patients nor does it provide Practitioners with the information required to follow up with purported patients (e.g., the Telemedicine Company does not require Practitioners to discuss genetic testing results with each purported patient).”
- And more.
“In the telehealth space, the issue the OIG has flagged is that genetic tests are being ordered without patient interaction or with only brief telephonic conversations,” Danielle Tangorre, JD, a partner at law firm Robinson & Cole LLP in Albany, N.Y., told Dark Daily.
New Bill May Eliminate 2023 Medical Laboratory Payment Cuts Under PAMA
Medical labs and pathology groups face payment cuts of up to 15% for 800 lab tests on the Medicare Clinical Lab Fee Schedule (CLFS) on Jan. 1, 2023, as part of PAMA.
However, a bipartisan bill is before Congress that may change things. The Saving Access to Laboratory Services Act (SALSA) seeks to accomplish three things:
- Eliminate the scheduled Jan. 1 price cuts.
- Reduce future payment decreases to the Medicare CLFS under PAMA.
- Reconfigure how CMS calculates lab test payments for the CLFS.
At last check, the bill was before the Senate Finance Committee. Proponents are hopeful a vote will come before PAMA’s Jan. 1 cuts occur.
The Dark Report explored the SALSA Act in detail in “PAMA Cuts Might Be Reduced to Zero for 2023.”
Changes to LDT Oversight in VALID Act Sidelined for Now
In “Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation,” Dark Daily reported on the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) and why its opponents believe it stifles diagnostic innovation.
The bill proposes to move regulatory oversight of LDTs from CLIA to the federal Food and Drug Administration (FDA). Champions of the bill argue that FDA regulation is needed for in vitro clinical tests (IVCTs) because they are similar to medical devices and bring with them patient safety concerns.
The bill seemed ready for a Senate vote over the summer but stalled. On Sept. 30, Congress passed a short-term resolution to keep the federal government funded. During negotiation, the VALID Act was removed from the larger spending package, according to Boston law firm Ropes and Gray.
Expect discussion to renew in Congress about the VALID Act after the mid-term elections.
Clinical laboratory leaders and pathology group managers will want to closely monitor the progress of these four federal legislative and regulatory developments. Each of the possible actions described above would significantly change the status quo in the compliance requirements and reimbursement arrangements for both clinical laboratory testing and anatomic pathology services.