Final Rule Reveals No Surprise

The CMS Two-Midnight rules continues to prompt questions.

Well, I finally read through the 1,394-page 2022 Outpatient Prospective Payment System (OPPS) Final Rule, and luckily, there were no great surprises.

As I mentioned previously, the Centers for Medicare & Medicaid Services (CMS) is now keeping the Inpatient-Only List alive, and adding back to the List most of those procedures removed this year. It took CMS 100 pages to discuss this policy change. When CMS finalized the two-midnight rule, that took only 47 pages. Here we are, eight years since the adoption of the two-midnight rule, and there are still questions – so perhaps having more pages dedicated to this reversal will lead to fewer questions in the future. I will go into detail about the changes in my December RACmonitor webinar.

A couple of other things in the rule did stand out and are worth mentioning. First, there are 110 different skin substitutes used for skin grafting. Who knew? Sounds like going to the olive oil aisle in the grocery store. Second, as usual, there were a bunch of new devices, with providers asking for approval for device pass-through payments, wherein the hospital gets additional money added to the outpatient payment if the device is used. This is the outpatient version of the new technology add-on payment system for inpatient admissions.

As with the Inpatient Prospective Payment System (IPPS) Final Rule, CMS denied approval for the device that scrubs the colon clean during colonoscopy. Overall, they denied 50 percent of the devices for which pass-through payments were requested.

Now, what happens when devices get turned down? Well, one of two things: the hospital and doctors evaluate the cost, realize there is no added payment, and choose to use it or not, depending on its potential benefit – or the manufacturer lowers the cost so that providers will find the cost-benefit ratio more beneficial and start purchasing it. That’s another side of hospitals that is little-discussed, but crucial: our colleagues in the supply chain.

They are also adopting an interesting quality measure: the rate of patient recalls for further imaging after a screening mammogram. It’s a fascinating issue – if there is too much additional imaging done, you subject patients to unnecessary radiation, cost, and anxiety. If there is too little done, you risk missing treatable cancers. But here is the problem: just like with observation, there is no right rate, because every facility’s patient population is different.

CMS even admits that, but they state that expert consensus and peer-reviewed literature support their chosen range of 5 to 12 percent. While this rate may be what is recommended by experts or what is commonly seen in hospitals, there is no data to support improved patient outcomes for facilities within that range. Will hospitals below that rate have to start recalling patients with normal exams, simply to avoid a penalty? Will hospitals above that rate recall fewer patients and miss cancers? Establishing quality measures without robust clinical outcome data has the potential to produce more harm than good.

Finally, there has been a lot of talk about the significant Medicare Part B rate increases announced Friday – and lots of bad information. Here is the truth. The Food and Drug Administration (FDA) approved Aduhelm, the new Alzheimer’s drug that costs $56,000 a year and is given intravenously, requiring regular brain imaging, under the accelerated approval process this year. So far usage has been minimal, but CMS was required to raise Part B rates, because they don’t know how many patients will get this treatment in 2022. They admit that they are planning for the worst-case scenario, that it is used a lot, and that it will cost Part B a lot of money. That’s how budgeting works. We can only hope that doctors realize that the medication has yet to demonstrate a clinically significant positive result, and won’t order it – and then 2023 premiums can go down.

Programming Note: Listen to Dr. Ronald Hirsch as he makes his Monday rounds on Monitor Mondays, 10 Eastern, sponsored by R1RCM.