Knowledge Base Article

Sometimes things in life are so complex that it becomes hard to understand them, let alone implement them or apply them in a practical manner. In healthcare, Medicare often seems to be the king of complexity. When reading Medicare regulations, sometimes the more you read, the more confused you become. You may find solace in this quote from Tom Peters, American author on business management practices – “If you’re not confused, you’re not paying attention.”

In August 2013, Medicare approved new coverage guidelines for the insertion of single and dual chamber permanent cardiac pacemakers. In summary, permanent pacemakers are covered for documented non-reversible symptomatic bradycardia due to either sinus node dysfunction or second and/or third degree atrioventricular block. National Coverage Determination (NCD) 20.8.3, as explained in MLN Matters Article MM9078 and the associated transmittals, also includes a list of conditions that are non-covered although some of these conditions will not prohibit coverage if the patient also has a covered condition (see – it’s already confusing). After a long wait, CMS finally released complex claims processing instructions for this NCD in February 2015. And they were complex – you must have one of these diagnosis codes, these diagnosis codes are ok but only with one of these other diagnosis codes, use the KX modifier on all claims, some coverage is at the discretion of the Medicare Administrative Contractor (MAC) – maybe too complex. Hospitals from all around the nation soon began reporting problems in getting their Medicare pacemaker claims to process.

Due to these claim processing issues, CMS rescinded and replaced the original transmittals on October 26, 2015. The revised transmittals instruct MACs to implement the NCD at the local level until CMS is able to revise the formal claims processing instructions. Providers may have to wait and see what edits, if any, their MACs put in place for these claims. However, all aspects of the NCD policy remain in effect.

So how should hospitals proceed in the mean time? Hospitals should

• Review and understand the pacemaker NCD,
• Only bill Medicare for permanent pacemaker insertion when the conditions of the policy are met,
• Submit claims with appropriate diagnosis and procedure codes,
• Seek guidance from your MAC about any other claim requirements,
• Monitor claims to make sure they are processing and paying appropriately and
• Watch for future communications from the MAC and/or CMS concerning claim requirements for pacemaker insertions.

Another complex NCD was also in the news recently. On October 30, 2015, the Department of Justice (DOJ) announced 70 settlements with 457 hospitals in 43 states for more than $250 million related to cardiac devices that, according to the DOJ, were implanted in Medicare patients in violation of Medicare coverage requirements. This issue involved implantable cardioverter defibrillators, or ICDs. Per the DOJ announcement:

“Medicare coverage for the device, which costs approximately $25,000, is governed by a National Coverage Determination (NCD). The Centers for Medicare and Medicaid Services implemented the NCD based on clinical trials and the guidance and testimony of cardiologists and other health care providers, professional cardiology societies, cardiac device manufacturers and patient advocates. The NCD provides that ICDs generally should not be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty. The medical purpose of a waiting period -40 days for a heart attack and 90 days for bypass/angioplasty - is to give the heart an opportunity to improve function on its own to the point that an ICD may not be necessary. The NCD expressly prohibits implantation of ICDs during these waiting periods, with certain exceptions. The Department of Justice alleged that from 2003 to 2010, each of the settling hospitals implanted ICDs during the periods prohibited by the NCD.”

The lesson to be learned here is that your hospital, as a provider, must follow Medicare coverage requirements at the national (NCD) and local (LCD) level even when these requirements are complex, confusing, or just plain onerous. If your hospital fails to do so, it risks non-payment, recoupment, and/or penalties.