News to Note – Summer 2021

• Data on the effects of the pandemic continues to come out. Last spring, hospitals saw the number of patients with non-COVID related illnesses plummeted as diagnoses such as stroke and myocardial infarctions seemed to disappear. A recent study from Kaiser in northern California confirmed those observations since they saw a 41% decline in hospitalizations for heart attacks but those numbers returned to normal during the summer and winter surges. Of course, the etiology is unclear. Were there fewer actual cases or did those patients choose to stay home? It will be important to continue to follow this data as well as the incidence of malignancies in the next few years since many people delayed screening exams. 
• The Centers for Medicare & Medicaid Services (CMS) announced that they have given the MACs permission to start auditing claims submitted for care during the public health emergency. 
• Aetna has notified ophthalmologists that they will need to get prior authorization before performing cataract extraction. Aetna said they expect to approve over 95% of all requests which raises questions about the usefulness of this change.
• Last month the Centers for Medicare & Medicaid Services (CMS) released a draft decision memo to update the NCD for oxygen. And while most of the changes were aimed at easing access to oxygen for patients with cluster headaches, they also slipped in two sections that are huge.
• The first proposal is that they are no longer going to require a certificate for medical necessity be completed for a doctor to prescribe oxygen. We need to celebrate that CMS may be finally getting rid of a form. The form though does put DME companies potentially in a bind. They counted on the certificate to document all the requirements to prescribe oxygen and now they will need pull it from the medical record. 
• The other proposed change is to remove the words “Chronic stable state.” That means the patient in the ED or hospital with an asthma or COPD exacerbation can get oxygen prescribed for home use if they are hypoxic. That’s a huge change if CMS finalizes it. The memo is out for comment now. 
• Two recent interesting OIG advisory opinions.
• The first allows Medigap plans to give patients a discount off their premium if they go to an in network hospital for care. The patients can earn $100 credit every benefit period where they receive part A care. For some seniors it may be enough to change behavior and save the plan money. 
• The other opinion was much more interesting. There is a new therapy for a specific type of blindness caused by a gene mutation. This therapy is a one-time injection into each eye and can only be done at a certified center by a specially trained doctor. There are 22 steps to prepare the medication and it is injected with a 41 gauge needle. The patient must stay supine for 24 hours and be checked frequently after the injection. The medication itself costs $442,000. But the opinion was requested because the company that makes the medication wants to pay for lodging and food for up to a month for eligible patients who live at least 100 miles from a treatment center. And the OIG said it was allowed which makes a patient centered exceptions to the inducement laws in select cases with serious illnesses. 
• Aducanumab (marketed as Aduhelm) (the new medication for Alzheimer’s disease) remains in the news. The FDA had already changed the description of the patients eligible for treatment, limiting it to patients with mild disease. There are planned hearings investigating how the drug was FDA approved when their advisory committee overwhelmingly recommended it not be approved. And CMS also posted a notice that there are starting a national coverage process and asking for comments. The problem is that the NCD process takes up to 9 months and it is unclear that CMS would completely refuse coverage for an FDA-approved medication under part B. What happens next will depend on when the drug company starts making the medication available for use. If that happens before the CMS decision memo is released, coverage for Medicare patients will be at the discretion of the MACs and theoretically they will cover it if the use matches the FDA labeled indication. We have already heard that Cleveland Clinic and Mount Sinai in New York will not be providing the medication in their facilities. But hospitals are not the issue. The real test will be office-based physicians. Medicare part B payment for intravenous drugs is made at the average sales price plus 6%. That means a doctor could make over $3,000 administering the medication over a year. Time will tell if physicians in private practice will follow the Cleveland Clinic and not offer the medication or will they see an incurable disease and a medication that has the potential to work and start providing it. If CMS or the MACs establish criteria for its use, physician advisors and the utilization review need to develop a process to ensure criteria are met. What about the patient hospitalized who happens to have dementia. Will the doctors be able to order the drug to administer while they are there? Many questions are yet to be answered. 
• Several of the MACs sent out a notice that physician claims for outpatient surgeries which are a part of the prior authorization program will be rejected if the prior authorization number is on the claim. For clarity, the program requires the hospital to obtain the prior authorization number and place it on their claim but many work with the physician’s office to get the auth. It would seem then logical that the office staff might record that number and it would end up on the claim thinking that would prevent a denial. But the opposite is happening. It seems to me that the claim processing system could be programmed to ignore the number if the physician office includes it instead of outright rejecting the claim. 
• While CMS last year made clear their plans to eliminate the inpatient only list, the recent proposed rules would reverse this. They are proposing to put all the surgeries back on the inpatient only list and go back to the old system of evaluating each surgery for removal. For now, those nearly 300 surgeries will remain off the inpatient only list. If the proposed rule goes through, they could potentially be back on January 1, 2022. 
• Controversially, the proposed rule also has a reversal of the addition of over 200 surgeries to the list of surgeries allowed at ambulatory surgery centers. The ASC industry is not happy since they have gone ahead and invested a lot to prepare and ultimately start doing some of those surgeries. Of note, CMS has already designated 9 that will continue to be allowed at ASCs, most notably total hip arthroplasty. 
• There is a lawsuit in federal court asking that Medicare patients be given immediate appeal rights if their status is changed from inpatient to outpatient. The Center for Medicare Advocacy has provided an update. The court has issued a temporary stay and that means not implementing the requirement while the full court makes a final decision. If patients whose status is changed are given appeal rights, the financial and operational logistics will be daunting. It is unclear at this point how the court will rule.