News to Note – March 2024

• As of January 1, Medicare Advantage (MA) plans are required to follow the provisions of the Centers for Medicare and Medicaid (CMS) Two-Midnight Rule.  Many believe MA plans can no longer use commercial criteria like MCG or InterQual to make coverage determinations, but this is not true.  Quoting from the final rule, CMS states, “when coverage criteria are not fully established in applicable Medicare statute, regulation, NCD [National Coverage Determination] or LCD [Local Coverage Determination], MA plans may create internal coverage criteria under specific circumstances.  In these circumstances, an MA plan is permitted to choose to use a product, such as InterQual or MCG or something similar, to assist in creating internal coverage criteria.”  
• Application of the Two-Midnight Rule is not the same as application of an NCD or LCD that has specific, quantifiable criteria such as non-reversible bradycardia.  Given this, commercial criteria can be used to help determine if the patient has medical necessity for ongoing hospital care.  Of course, there will always be cases that don’t fit within criteria, which is where the crucial role of the physician advisor comes in – to review those cases and determine the need for hospital care.
• What must the MA plan do to use these tools?  CMS states, “the MA plan must provide, in a publicly accessible way, the internal coverage criteria in use; a summary of evidence that was considered during the development of the internal coverage criteria used to make medical necessity determinations; a list of the sources of such evidence; and an explanation of the rationale that supports the adoption of the coverage criteria used to make a medical necessity determination.”  That’s a pretty high hurdle but Humana, at least, has met it with the use of MCG’s new Medicare criteria tool that allows public access, has the evidence base listed to support their criteria, and even includes a statement that inpatient admission is indicated if the patient requires hospital care that would pass the second midnight, exclusive of delays and convenience or if any of the CMS designated exceptions are met. 
• As such, if an MA plan denies inpatient admission for a patient who’s hospital stay meets the qualifications of the Two-Midnight Rule by referring to criteria, consider asking them for a publicly available copy of the criteria they are using and notifying them that if they are unwilling or unable to provide it, you will be reporting them to CMS for violating federal regulation, 42 CFR 422.101 (6)(ii). 
• Last month, CMS sent MA plans a Frequently Asked Questions (FAQ) notice on what they can and cannot do in 2024 with the new regulations.  Shout out to our own President Emeritus, Dr. Edward Hu of UNC Health, who obtained a copy of the document and shared it.  In the near future, it will be available on our Government Affairs Committee page, but for now, you can find it here.
• Highlights include continued emphasis on how MA plans must utilize the Two-Midnight Rule and their ability to also use commercial criteria as noted above, but also the use of Artificial Intelligence (AI) tools to limit or deny access to post-acute care.  Similar to the use of MCG criteria, CMS does not ban the use of these AI tools but stresses that before denying or limiting care, the plan must assess the patient’s needs compared to the CMS requirements.  In other words, if the tool predicts an Inpatient Rehabilitation Facility (IRF) stay of eight days but on day eight the patient still meets Inpatient Rehabilitation Facility (IRF) requirements, the MA plan cannot deny continued care.  
• Importantly, AI tools are appropriate for service approval – if set criteria is met, it should be approved without need for a physician review or request for additional medical records.  But, if the criteria are not met, the evaluation process must take additional steps, be it referring to a physician advisor if inpatient admission is in question so they can review for ongoing medical necessity for hospital care, or in the case of post-acute care comparing the patient’s current needs to CMS criteria.
• CMS also scolded MA plans for approving inpatient admissions and then after discharge, denying payment not as a level of care denial, but as a payment review denial.  If you have received those kinds of denials, get the FAQ and pass it on to your appeals team.
• It was recently discovered that at least three Medicare Administrative Contractor (MAC) educational pages about Observation services, all updated in 2023, include, “Outpatient observation services generally do not exceed 24 hours” which completely does not jibe with the Two-Midnight Rule.  
• They also continue with, “the order for outpatient observation services must be in writing and clearly specify outpatient observation.  The order must include the reason for observation, services ordered and be signed, dated and timed by the physician responsible for the patient during his/her outpatient observation care.”  While dating and timing the order is reasonable, there is no regulation or mention in any manual requiring the order to specify the reason for observation services.  Will these MACs deny observation claims for physicians and hospitals when the reason is not in the order?  Also, does, “in writing” mean electronic orders will not be accepted?
• The direction that the order should specify services related to observation is also troublesome.  Observation IS a service, not a status in which services are provided.  Granted, perhaps they are referring to the definition from CMS that states, “Observation care is a well-defined set of specific, clinically appropriate services” where they unfortunately never define what services would suffice.  Do every eight-hour vital signs fit the bill?  This was never made clear by CMS.
• Each year, Medicare readjusts its payment rates.  They do this by employing a complicated process involving review of past claims, analysis of costs, review of the Medicare Trust Fund and applicable laws, and ultimately deciding how much they will pay for every single service which can be provided to a beneficiary.  Physician payment rates always seem to be at risk of drastic cuts, but per laws enacted by Congress, CMS cannot simply raise rates to pay physicians equitably.  This year, it appears CMS realized that continued physician payment cuts for office visits were going to cause trouble and decided the easiest way to balance the required cut in payment for office visits was to establish a new add-on code.  
• Now, one office visit can be coded with two codes leading to a higher payment given the addition of code G2211.  Of course, there is a long and complicated definition detailed in a transmittal and MLN Matters to meet the letter of the law for new codes. 
• Which office visits should use code G2211?  It seems all should, even when it is a new patient visit, with the exception of visits involving urgent care centers or Emergency Departments.  
• CMS provided an example of a patient presenting to their primary care physician with sinus congestion.  There is no indication that the patient has any chronic medical illnesses or that their care was complex.  In the words of ACPA Update Editor and ACPA Advisory Board member Dr. Ronald Hirsch, “if seeing a perfectly healthy patient with a runny nose and prescribing Kleenex qualifies for G2211, then every other patient qualifies for it.”
• Unfortunately, CMS excludes the use of G2211 when the patient is given a vaccine during the office visit, which does not feel to make sense given the spirit of G2211 is encouragement of the development and support of a trusting relationship between the doctor and patient.
• Can G2211 be used for hospitalized patients?  This is not yet clear as some hospital visits use codes 99202 to 99215 and there is no mention of place of service by CMS when using this new code.
• Finally, perhaps one of the biggest bits of news from CMS last month was their announcement that secure texting of orders is now allowed but you must pay attention to the “secure” part of this declaration.  Not any type of texting mechanism will be compliant.