ASCLS - Washington        

Government Affairs Committee (GAC)

e-newsletter

#7 –June 2011

One of the strategic goals of our committee for is to improve communication to the broader ASCLS membership and to provide a more consistent face to our members. The GAC e-newsletters are also available on the ASCLS Advocates for You section of the ASCLS website.

In this issue…

· Healthcare reform update

· Physician Signature requirement rules to be pulled

· Laboratory Developed Tests

· State activity: Licensure

· See you at the annual meeting in Atlanta

Health Care Reform Update

Modernization of the Medicare Clinical Laboratory Fee Schedule: Next steps in the healthcare reform bill – The Affordable Care Act – will likely take place in Congress late this summer or in the fall. There will be a process called reconciliation, which should provide the opportunity for the laboratory profession to advocate for the modernization of the clinical laboratory fee schedule. In the First Session of the last Congress, H.R. 1452 was introduced:

• To require the Secretary of Health and Human Services to enter into negotiated rulemaking to modernize the Medicare part B fee schedule for clinical diagnostic laboratory tests and to amend title XVIII of the Social Security Act to adjust the fee for collecting specimens for clinical diagnostic laboratory tests under the Medicare Program. http://thomas.loc.gov/cgi-bin/bdquery/z?d111:H.R.1452:

The need to modernize the clinical laboratory fee schedule is as pressing as ever. We are operating under a fee schedule that reflected the reality of laboratory medicine in 1984 and the fee schedule sorely needs to be updated to reflect today's practice and technology. Legislation that will ensure patient access to evidence-based medicine, involve relevant stakeholders, create mechanisms for periodic updates and modernize the fee schedule to reflect changing cost and enhanced technology must be enacted.

Provisions from the 2009 bill should be retained to make all parties accountable for the outcome of the process. Some of the provisions include:

• Using negotiated rulemaking to assure Congress that the best consensus on a clinical laboratory fee schedule was attempted.
• A time limit of two years from the convening of the negotiated rulemaking committee.
• A committee to be comprised of all stakeholders: laboratory professionals, physicians, hospitals, independent laboratories, Medicare, private payers, etc.
• Requiring the Medical Payment Advisory Commission ("MedPAC") to issue a report on the Committee's fee schedule, or, in the case that the Committee fails to reach consensus, make its own recommendation on how to modernize the fee schedule.
• Mechanisms to maintain the same aggregate payments for the new schedule as would have been made under the old for the first year
• Periodic updates, a transition period and no beneficiary cost sharing that will enable clinical laboratories to continue to provide advanced, accurate and effective tests to all patients.

When Congress begins to consider and take action on healthcare reform, we will be asking members to advocate for this process and to ask their senators or representatives to consider being a sponsor of this important legislation.

Laboratory co-payment: As the Federal government grapples with solving it budget deficit, ways of raising revenue, to offset costs, are continually sought out. Like a bad penny, one of the revenue solutions that keeps getting raised is the implementation of a 20% Medicare co-payment for clinical laboratory services. Most other services have a co-payment provision, but as part of the negotiation in establishing the clinical laboratory fee schedule in 1984, the laboratory community agreed to the fee schedule "in exchange for” not having a co-payment provision for outpatient laboratory services.

Right now both the House and President's budget proposals include the establishment of a co-payment. Basically this would require the Medicare beneficiary to have to pay 20% of their laboratory services bill and Medicare would pay for the remaining 80%. There are many concerns about a co-payment on laboratory services. Among them are:

• With Congress's goal of reducing utilization, a co-payment is paid by the patient and not the ordering physician and therefore it is felt that utilization will not be impacted significantly.
• It will dramatically raise costs in the laboratory since the laboratory will need to send out a separate bill for the co-pay amount. Since we do many tests with very low reimbursement, the cost to bill for the services will often exceed any reimbursement received. For example, with a $10 test, we would be trying to collect $2.00. Many would consider that not billing for the co-pay would be the easier route, with less financial impact on the laboratory.
• Could reduce broad access to quality laboratory services since some laboratories might choose not to provide services for Medicare patients.

Physician Signature requirement on laboratory requisitions