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3 Key Legal and Regulatory Issues for Pain Management Practices

At the 12th Annual Spine, Orthopedic and Paine Management-Driven ASC Conference in Chicago on June 14, Meggan Michelle Bushee, JD, associate at the law firm McGuireWoods, and Victor L. Moldovan, JD, a partner at McGuireWoods, talked about key legal and regulatory issues pain management practices face.

Here are three key issues Ms. Bushee and Mr. Moldovan discussed.

1. Varying state monitoring requirements and CMS coverage regulations.  "If you're doing pain management, you absolutely have to do urine testing," Mr. Moldovan said. "Lots of patients will abuse medication. The fact is it'll interfere with the plan of care you establish for them. The question is, how often do you test?"

Because of issues with "pill mills," lawmakers in states such as Georgia and Kentucky have adopted more restrictive regulations for how pain management practices monitor patient compliance. Mr. Moldovan said pain management practices must therefore be aware of their state's specific laws. "Some states have not adopted the specific rules so far, but it's coming in every state at some level," he said. "These are things that you have to constantly manage."

Additionally, Ms. Bushee said pain management practices must comply with regulations from CMS in the form of local coverage determinations about when confirmatory drug tests are considered medically necessary. These are issued by Medicare administrative contractors and can vary across MAC jurisdictions, she said. "We don't have a clear national coverage determination that's been issued on this," she said. "We only have these local ones."

2. Legal battles between testing companies. There has been a lot of litigation involving testing companies suing each other, each claiming the other one is trying to induce physicians to use their particular lab tests. Pain management practices can get caught up in these cases, Mr. Moldovan said.

"As these companies sue each other…eventually it's going to roll onto your practices," he said. "We're getting clients actually getting demands for records for the past five years," concerning who ordered lab tests and other information. Therefore, pain management practices must ensure they thoroughly document the medical necessity for tests.

3. In-office lab compliance. Many pain management practices use labs so frequently that they're beginning to look into establishing in-office labs, Ms. Bushee said. This course of action can lead to quicker turnarounds on test results, increased revenues for the practice and other benefits.

However, in-office labs receive plenty of regulatory scrutiny. "It's definitely something that you want to make sure, if you set one up, that you comply with all the local laws," she said.

Practices must be prepared to have auditors ask if they have a standing order to perform a confirmatory lab test for everyone who walks in the door, Mr. Moldovan said. "You really can't do that," he said. "It's not medically necessary." He advised establishing a compliance audit program to ensure the testing rate isn't 100 percent and there are criteria for testing patients.

There are also location, supervision and billing requirements, among other regulations, practices must consider if they establish in-office labs. Ms. Bushee advised turning to the state's Clinical Laboratory Improvement Amendments office. "Every state has at least one CLIA regional office," she said. "That's always a good starting point. They should be familiar with not only the federal requirements but also the state requirements."

More Articles on Pain Management:
The New Paradigm of Pain Management: 3 Key Concepts   
Changing the Way We Look at Pain & Functional Outcomes in Spine Surgery  
5 Key Thoughts on Pain Management This Year 

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