Cardiology & Medical Necessity: How Your Hospital Can Avoid Heart-Related Investigations

This past August, the U.S. Department of Justice sent guidelines to hospitals that dealt with the medical necessity of implantable cardioverter defibrillators, or ICDs.

The guidelines were released to help with the settlement of claims stemming out of the DOJ's investigation on ICDs that were placed in Medicare beneficiaries between 2003 and 2010 at hospitals. Hundreds of hospitals stand to face False Claims Act penalties for improper use of ICDs as a result of the investigations, which as most hospitals going through fraud and abuse measures right now know can be a very costly process.

ICDs have been heavily scrutinized by governmental agencies for roughly the past five years, especially considering the cost of implanting ICDs can range between $30,000 and $40,000. Beyond ICDs, cardiac care in general has been a lightning rod of scrutiny due to the high costs and high amounts of fraud associated with it. This past August, a New York Times investigation alleged that Nashville, Tenn.-based Hospital Corporation of America performed medically unnecessary cardiac catheterization procedures from 2002 through 2010.

Here are some quick steps hospitals can take to make sure their physicians are being prudent in their discretion of cardiac-related procedures and devices.

1. Document everything. Lee Lasris, JD, a founding partner of the Florida Health Law Center in Davie, Fla., has represented numerous hospitals and health systems over the past 30 years. When it comes to cardiac care, like most other Medicare covered items and services, he says it is essentially a medical necessity determination. Medicare wants to be sure that high-dollar procedures and implants, like ICDs and stents, are being utilized only when medically necessary and not for the convenience of the physician.

CMS defines medical necessity in its national coverage determinations, which are the definitive guidelines of whether Medicare will pay for an item or service. When it comes to ICDs, NCD 20.4 governs Medicare's payment of ICDs and can be found on CMS' website. Some stipulations include the timing of when ICDs are implanted: heart attacks must occur more than 40 days prior to ICD insertion; the diagnosis of heart failure must occur more than three months prior to ICD insertion; angioplasties or bypass surgeries must occur more than 90 days prior to ICD insertion; etc.

Mr. Lasris says while there are well-meaning physicians who want to insert ICDs sooner rather than later — for example, when the patient is already on the operating table for a different procedure — the NCD must be kept in mind, and legitimate medical reasons for doing so must be well-documented if the physician wants to avoid the claim being denied for failure to follow the guidelines.

With that in mind, the greatest defense a hospital can have to justify its use of ICDs and other cardiology-related procedures and devices is clear, coherent, reasonable and legitimate documentation. Educating physicians on the specific documentation requirements is one of the most important things a hospital can do to ensure its rationales are solid and able to be traced. The DOJ's resolution and guidelines highlight specific documentation requirements, and hospitals and their physicians must sit down and have a plan of action for their future ICD documentation.

"You need to be able to document why you did something," Mr. Lasris says. "If there's a good reason, Medicare will eventually pay it. Medicare is a reasonable payor."

Tony Brett, JD, a partner with Womble Carlyle Sandridge & Rice in Winston-Salem, N.C., who also works with hospitals, agrees that physician documentation, in accordance with Medicare guidelines, will keep hospitals and physicians in the clear. "If your physicians can justify what you're doing, OK. You can sleep better at night," Mr. Brett says. "But you have to know if the problem is the implantations themselves or the documentation. Physicians are busy and would rather treat patients than treat paper. They may not realize all the things they need to document."

2. Self-audit. Instead of awaiting notices from the DOJ or Office of Inspector General, hospitals should remain proactive and ensure that their cardiology processes are legitimate through self-audits. Hospitals may already be self-auditing themselves for other fraud and abuse measures — such as those instigated by Medicare Recovery Auditors, or RACs — and Mr. Brett says hospitals and physicians should take the time to self-audit on cardiology procedures, especially if they believe there may have been inappropriate ICD or stent insertions in the past.

"If you think you have might have an issue, you ought to look at the implantations that have occurred," Mr. Brett says. "Do they match up with the criteria? If not, is there documented rationale that would be recognized by physicians in the area that would be used as justification?"

Monthly self-audits may seem like another administrative burden, but they very well could be cheaper in the long run as hospitals could avoid unintentional federal violations. "It's always cheaper to self-report and stay under the False Claims Act," Mr. Lasris says.

3. Talk with peers. Hospitals and physicians need to collaborate not only amongst each other, but also with peers, to see if their rate of ICD implantation is comparable with state and regional averages. Simply talking with peer institutions can give hospitals a clearer idea of whether they may flag interest from government regulators.

"Consult with a peer," Mr. Brett says. "It's not to say two people can't be wrong, but it's less likely."

4. Don't be afraid to ask the government questions. Alberto Gonzales, JD, former U.S. Attorney General under President George W. Bush and now an attorney at Waller Lansden Dortch & Davis, says the DOJ will review the ICD implantations at hospitals on a case-by-case basis. The guidelines and resolution model will help with settlements regarding the DOJ's investigation. Overall, Mr. Gonzales believes most hospitals will settle, depending on their individual cases.

However, hospitals in dialogue with the DOJ should use the opportunity to make sure every party is on the same page. No one likes to be investigated by the DOJ, or any other prosecutor, so hospitals should ask the important questions to ensure there is no confusion in the future, he says.

"When I worked with the DOJ, I always found things were better when there was ongoing communication with the prosecutor," Mr. Gonzales says. "If there are questions, ask. Sometimes, it's a good idea to consult with the DOJ if you want to do something, or take certain action. Run your concerns by the investigator or prosecutor to make sure they are OK with it."

More Articles on Hospital Cardiology Legal Issues:

St. John Medical Center in Cleveland Probes Unnecessary Stenting

Court Upholds 10-Year Sentence for Louisiana Cardiologist Who Billed for Unnecessary Procedures

Investigative Report Drives Scrutiny Over HCA's Cardiac Care

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