Pennsylvania Department of Health Reconsiders Laparoscopy Decision
Posted by Clark Venable on 3/13/2005
In a letter to ambulatory surgery centers dated March 7, 2005 and available on a DOH web site, the department has decided to place the issue under further study and to grant exceptions to the prior directive to allow some centers to resume certain laparoscopic procedures:
"Following its notification to providers that procedures such as laparoscopic cholecystectomies were not permitted in the ASF setting, some ASFs objected that some of these procedures were safe and should be allowed.
In response to these providers’ concerns, the DoH proceeded to meet on a number of occasions with the Pennsylvania Medical Society, the Federated Ambulatory Surgery Association and the Pennsylvania Ambulatory Surgery Association. We reviewed the applicable literature made available to us by provider organizations and through our own research. We worked with the Pennsylvania Health Care Cost Containment Council to collect available data into formats that would be helpful. We found that some ASFs were performing procedures that the DoH believes to be prohibited under its regulations. We also surveyed other states and found that Pennsylvania is more restrictive than other states, which tend to rely upon Medicare to control the types of procedures performed in ASFs.
The DoH agrees that providers have raised valid points and proposes to convene a group of stakeholders to review the current regulation and determine what changes are appropriate. This process, however, will take time and some providers that have been performing these procedures on a routine basis need more immediate relief. Therefore, the DoH has implemented the following two-pronged exceptions process.
In addition to the procedures allowed under the state regulations, the DoH has determined that ASFs should have the opportunity to perform procedures that are on the Medicare List since these procedures have been reviewed and approved by the federal government on a procedure-by-procedure basis for their safety in a freestanding ambulatory setting. This list is developed under § 1833(i)(1) of the Social Security Act, which requires CMS to specify surgical procedures that can be safely performed in a freestanding ambulatory surgical setting. The Medicare List is published in the Federal Register as an addendum to 42 CFR Part 416"
In response to these providers’ concerns, the DoH proceeded to meet on a number of occasions with the Pennsylvania Medical Society, the Federated Ambulatory Surgery Association and the Pennsylvania Ambulatory Surgery Association. We reviewed the applicable literature made available to us by provider organizations and through our own research. We worked with the Pennsylvania Health Care Cost Containment Council to collect available data into formats that would be helpful. We found that some ASFs were performing procedures that the DoH believes to be prohibited under its regulations. We also surveyed other states and found that Pennsylvania is more restrictive than other states, which tend to rely upon Medicare to control the types of procedures performed in ASFs.
The DoH agrees that providers have raised valid points and proposes to convene a group of stakeholders to review the current regulation and determine what changes are appropriate. This process, however, will take time and some providers that have been performing these procedures on a routine basis need more immediate relief. Therefore, the DoH has implemented the following two-pronged exceptions process.
In addition to the procedures allowed under the state regulations, the DoH has determined that ASFs should have the opportunity to perform procedures that are on the Medicare List since these procedures have been reviewed and approved by the federal government on a procedure-by-procedure basis for their safety in a freestanding ambulatory setting. This list is developed under § 1833(i)(1) of the Social Security Act, which requires CMS to specify surgical procedures that can be safely performed in a freestanding ambulatory surgical setting. The Medicare List is published in the Federal Register as an addendum to 42 CFR Part 416"
A PDF of the letter is uploaded here. On balance, I think this is a fair approach (for now), and a great improvement over the wholesale banning of all laparoscopic procedures at centers that provide a very high standard of care.
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