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History and Accomplishments

The New York State Clinical Laboratory Association, known as NYSCLA, is a non-profit trade association and the premiere advocate for clinical laboratories in New York State. NYSCLA was formed in 1988 as a direct response to the Medicaid program’s attempt to implement a competitive bidding process for laboratory services. Laboratories from across the state came together and, working with the legislature, convinced the Medicaid program to drop its competitive bidding approach. Laboratories saw how influential they could be working together, and NYSCLA was born.

Eliminating competitive bidding, a process that would have hurt many laboratories by removing them from the Medicaid provider network, was NYSCLA’s first major accomplishment, but there have been many more.

At a time when health care was becoming more and more regulated, NYSCLA developed relationships with the Department of Health, the Medicaid program, the Medicare program, the legislature, and the governor’s office.

Negotiations started almost immediately with the Medicaid program to increase reimbursement rates, and we persuaded the legislature to transfer responsibility for enforcing and interpreting the business practice law from the Attorney General’s office to the Department of Health, which had committed to playing a stronger role in the creation of the “level playing field” that had been sought by laboratories.

NYSCLA uses persuasion as a first step in effecting change, but from time to time we have had to be more forceful. When the Medicaid program took an unreasonable position in telling laboratories how to design requisition forms, and would not move from its position, we sued the Medicaid program – and won.

A judge told the Medicaid program that their proposed restrictions were unlawful and ordered the program to allow laboratories to design requisition forms in a much more user friendly way and, at a time when no fee schedule increase had been given to any Medicaid provider, we persuaded the Medicaid program to increase the reimbursement for Pap smear testing to a reasonable level. The Department of Health and its Medicaid program now work closely with NYSCLA, soliciting our input on regulatory and fee schedule matters.

 

NYSCLA Highlights

  • NYSCLA achieved a huge victory by convincing the legislature to eliminate a surcharge tax that was very harmful to laboratories. The legislature and the Governor’s office have developed close ties with NYSCLA, requesting our input on new legislation before it is enacted.
     
  • We worked with the Department of Health’s Wadsworth Center to update the antiquated business practice and self-referral regulations and in the process developed a helpful system for requesting interpretive opinion letters from the Department of Health. This system is used on numerous occasions throughout the year to obtain clarification on regulatory and statutory requirements.
     
  • At NYSCLA’s request and in view of the improved technology available to perform PAP testing, the Wadsworth Center modified its workload standards for cytotechnologists.
     
  • When the Department of Health proposed new general QA standards that may have confused the definition of what constituted genetic testing, NYSCLA objected to the new standards, and they were withdrawn.
     
  • NYSCLA worked with the Medical Society of the State of New York (MSSNY) and the Medicaid program to rewrite regulations that greatly revised the requirement for obtaining physician signatures on requisitions. The new regulations also, for the first time, recognized the validity of standing orders.
     
  • NYSCLA worked with the American Clinical Laboratory Association (ACLA), the Healthcare Association of New York State (HANYS), the New York State Society of Pathologists (NYSSPATH), and the American Association of Bioanalysts (AAB) to submit a joint proposal to the Spending and Government Efficiency Commission regarding duplication of efforts by Wadsworth. These efforts led to Wadsworth’s recognition of other entities’ proficiency testing and, ultimately, the complete elimination of NY State proficiency testing.
     
  • On the federal level, NYSCLA has been selected by CMS to serve as the laboratory industry representative on the Medicare Carrier Advisory Committee (CAC) in New York State. All new, draft Medicare policies, including laboratory policies, are reviewed by the CAC before being finalized and implemented.
      
  • When the United States Congress proposed to reinstate the 20% co-pay for all laboratory services, NYSCLA worked closely with the AAB & ACLA to successfully defeat the 20% co-payment.
     
  • NYSCLA supported multi-prong efforts to invalidate the Food and Drug Administration’s attempts to regulate laboratory developed tests.
     
  • NYSCLA continues to work with other associations, including ACLA, to battle against PAMA cuts to Medicare laboratory reimbursement.