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Comment Period for PAMA

The Centers for Medicare and Medicaid Services (“CMS”) released its preliminary PAMA rates on September 27, 2017. The rates and background information from CMS can be found at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html.

The comment period ends October 23, 2017, and it is imperative that affected laboratories and other interested parties submit their concerns to CMS before the end of the comment period. All comments must be submitted electronically:

• You can email CMS directly at CLFS_Annual_Public_Meeting@cms.hhs.gov.  
• Comments can be submitted to both CMS and Congress through a link on The American Clinical Laboratory Association  (ACLA) website:   http://cqrcengage.com/acla/app/write-a-letter?0&engagementId=400493 

It is clear that the proposed cuts would be devastating to many laboratories, and may substantially and adversely affect the access of many patients, particularly in underserved areas, to laboratory services. Nine of the top 10 laboratory codes and 18 of the top 25 codes would see reductions in payment of more than 30 percent after the PAMA rates are fully phased in. Payment for a comprehensive metabolic panel will fall 37 percent. CBC rates will fall 35 percent. Vitamin D testing rates will fall 35 percent. Payments for HbA1c will decline 36 percent. TSH rates will decline 35 percent. Furthermore, payment for the lipid panel, CPT 80061, would be cut by 39 percent in the first year, even though PAMA regulations prohibit more than a 10 percent decline in any given year.

The preliminary PAMA rates obviously do not reflect the Congressional intent of “market based” rates. Fewer than one percent of all laboratories reported data to CMS upon which the preliminary rates are based. Only 0.7 percent of laboratories reported data to CMS under PAMA. Importantly, approximately 85% of the laboratories that the Office of the Inspector General previously estimated would report data to CMS failed to report any data under PAMA.  (see Summary of Data Reporting for the Medicare Clinical Laboratory Fee Schedule (CLFS) Private Payor Rate-Based Payment System)

Clearly the lack of market based reporting calls into question the integrity of the data upon which the preliminary PAMA rates are based. In addition, the fact that CMS did not issue a final rule explaining the reporting obligations until the end of the data collection period likely led to inaccurate or incomplete reporting, particularly given the substantial resources needed to comply fully with the rule.

NYSCLA urges its concerned members to submit their comments to CMS by the October 23, 2017 deadline.