ACPA Newsletter
April 2021
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Finalized & Retracted: Medicare Coverage of Innovative Technology |
Must the Physician Advisor Continue to Practice Clinically? |
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Ronald Hirsch, MD, FACP, CHCQM-PHYADV, CHRI |
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I write this on Friday, March 19, better known as Match Day 2021. Twitter is full of many doctors posting their match location with absolute delight and receiving congratulatory tweets from doctors around the country. But this celebration actually began 5 days prior on Monday when medical students were notified if they had matched or not but not where they matched. I thought back to 1988 when I finished medical school and had no recollection of such a process. As if the getting through medical school is not bad enough, the system makes these poor students wait all week wondering where they will be going. And of course for some who did not match, the scramble starts to try to find an open slot through a program called SOAP, the supplemental offer and acceptance program. I am sure many of you will be meeting these new doctors on July 1st and will try to get some time to explain to them the two midnight rule, the importance of documentation, and urge them not to overuse copy and paste.
In this month’s newsletter you will find some great articles. If you don’t think that a few determined people cannot make a difference and change a rule that does not make clinical sense, read the article by Dr. Updike and colleagues at University of Colorado Medical Center who actually got AHRQ to change their quality coding rules. What an amazing accomplishment. Also read the article by Dr.Markiewicz where he discusses his journey from hand surgeon to physician advisor. His story shows that there is no typical course from clinical medicine to physician advisor and that building and maintaining clinical credibility can be accomplished as long as you are motivated.
Finally, please keep Dr. Edward Hu, a past ACPA president, in your thoughts and prayers. He wrote an article for this issue about a new CMS rule and two hours after he sent it to me, CMS withdrew the rule for further comment and consideration. But I did not want him to have to tell his children his article was rejected by the ACPA newsletter editor so I am publishing it in this issue. I suspect the rule will be eventually adopted so reading his summary will put us all ahead of the game. Thank you Eddie, your secret is safe with us.
Watch next month for the results of the March Observation cases and more. I welcome any submissions but will not beg. Ok, I’m begging. Please send an article of any length on any topic to me, please.
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Finalized & Retracted: Medicare Coverage of Innovative Technology |
Edward Hu, MD, CHCQM-PHYADV
ACPA Board of Directors
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Editor's Note: On March 15, 2021 a new CMS coverage policy went into effect, termed Medicare Coverage of Innovative Technology (MCIT). Two days after the effective date, CMS posted a delay in the effective date to May 15, 2021. CMS is soliciting comments by April 16 on whether the MCIT Final Rule should be amended, rescinded, or further delayed.
In an effort to speed the availability of new device technology, the Medicare Coverage of Innovative Technology (MCIT) rule that would provide CMS coverage for 4 years for a device that gains FDA market authorization through the FDA Breakthrough Devices Program pathway.
The Breakthrough Devices Program was established by the 21st Century Cures Act for devices that potentially are more effective than existing technology and are different than alternatives available on the market currently. Although many candidate devices may enter the program, not all are guaranteed to receive FDA market authorization. Only devices that make it through to receive market authorization would be covered by Medicare (and become FDA approved).
On the date of FDA market authorization, these devices would become eligible for immediate Medicare coverage for “on label” usage. Although the manufacturer can delay the coverage start date for up to 2 years, coverage under MCIT would terminate 4 years from the FDA market authorization date. CMS encouraged manufacturers to use the 4 years of coverage to collect additional clinical information and perform studies, to inform Medicare coverage policy after the 4 years are over. If the data do not support ongoing coverage, then the device could lose Medicare coverage. After the 4 year mark, Medicare coverage would be determined as it otherwise is today – via NCDs, LCDs, or on a claim-by-claim basis by the MAC. Of note, CMS may terminate MCIT coverage if the FDA issues a medical device safety communication, a warning letter, or if FDA market authorization is revoked.
“A Definition of Reasonable and Necessary”
Medicare also finalized a codified definition of “reasonable and necessary” that would not only apply to MCIT device determinations, but also establish a standard that would be applied throughout Medicare Parts A and B. The Social Security Act has long contained language that most services are required to be “reasonable and necessary” for the treatment of illness or injury or to improve the functioning of a malformed body member. The would-be definition is:
- Safe and effective
- Not experimental or investigational
- Appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is-
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
- Furnished in a setting appropriate to the patient’s medical needs and condition;
- Ordered and furnished by qualified personnel;
- One that meets, but does not exceed, the patient’s medical need; and
- At least as beneficial as an existing and available medically appropriate alternative
However, CMS also finalized an alternative to meeting criterion (3), if (1) and (2) are met, that would be based on coverage by commercial policies for a majority of covered commercial lives. But which one of the criteria in (3) could you fail? I certainly hope a service will never fail a, b, or c! So, it must be either d or e. Exactly how CMS is going to determine this is not yet clear, except that CMS gave itself one extra year (until March 15, 2022) to propose the details – unless it decides to further amend or rescind this finalized rule by May 15, 2021.
Dr. Edward Hu is System Executive Director of Physician Advisor Services of UNC Health.
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Must the Physician Advisor Continue to Practice Clinically? |
Andrew D. Markiewitz, MD, |
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Editor’s Note: A recent RAC Relief post led to an interesting discussion. A health system’s physician advisors were continuing to practice clinically to maintain knowledge and credibility in the clinical world and it was asked what percentage of clinical v. administrative time was appropriate. Dr. Al Gore, a member of the ACPA Board of Directors suggested including the following was the response from ACPA Member Dr. Andrew D. Markiewitz in the newsletter.
Interesting discussion regarding time and training. All good points.
However, I'm going to stir the pot.
I trained to be an Orthopaedic Hand Surgeon. I remained a physician first and routinely diagnosed diabetes, gout and rheumatologic conditions among my patients. In my time, I diagnosed chest pain, strokes and myalgias from drugs.
Regretfully, I had to step back from practice, completely. I work, in theory, part time from home but my hours have expanded as allowed (I average 35/week). By being consistently available and timely in my response, I find more opportunities to work with our team.
When I took the PA job, I sought to become an expert. I got immersed in Monitor Monday, Top Gun, Appeal Academy, the ACPA, etc. I am Board certified. I am fluent in MCG use and listen to Dr. Hirsch and R1 whenever I get a chance.
Am I medicine trained? No. Can I understand medicine? Yes. I joke that I have read more Harrison's than I did in medical school. In April, I will attend a 6 day refresher course in Medicine given by the University of Cincinnati in association with the Academy of Medicine. Why? To be better.
I think the better questions is what makes a good PA? Buffett likes to say: “You're looking for three things, generally, in a person,” says Buffett. “Intelligence, energy, and integrity. And if they don't have the last one, don't even bother with the first two.” In surgery, we said "affable, available, and able." Likewise, if your surgeon isn't able, the first two don't matter.
My fellow docs work with me and seek out our guidance as the PA program is known to collaborate. We let the docs manage the practice of medicine while we manage the business of medicine. Our group now tracks the calls from docs as it has become a 2-way street.
Our program teaches the basics of being a PA to our new hires. We are selective in who is considered. Thus, our turnover is non-existent. Our PA system is further supported by an outstanding group of UR nurses who give us a running start.
Being a surgeon, who can also speak medicine, allows me to raise the bar in P2Ps, especially when they try to interpret surgical prudence with delay.
Thus, to sum it up, pick an intelligent doctor, physician or surgeon; teach them well; give them the support needed to succeed; and provide coaching. Determine what you need from a PA program in terms of FTEs, etc. and develop your team.
All thanks to my teachers, Linda Hogel, Dr. Feghali, and Dr. Hirsch.
Andrew D. Markiewitz, MD, MBA-Healthcare, is a Physician Advisor, ABQAURP Certified, ABOS Certified, at TriHealth, Inc in Cincinnati, OH.
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John A. Updike M.D., M.P.H., F.A.C.P.
Debra L. Anoff, M.D., F.H.M., F.A.C.P.
Alyson Dare Kelleher, B.S.N., R.N., CCRN-K
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Introduction
How many times have you had a provider immediately respond, “the coding must be wrong,” when you engaged in a quality discussion? And, after you went in circles (and took several detours) explaining the documentation, the coding, and the metric’s definition, how much time was actually left to talk about bedside patient safety?
Providers’ default of disbelief is often anchored by suspicion in how the ‘data’ is derived – the inclusion and exclusion criteria seemingly live behind a curtain few peek behind, and even fewer completely understand. But the details matter, because they populate the dashboards and scorecards most providers receive. In this article, a Clinical Quality Specialist nurse threw open the curtain, helped shine some light on a previously unidentified misrepresentation of quality, and sparked change in an AHRQ metric on a national level.
Background
In 2018 CMS reassigned the Major Diagnostic Category (MDC) for congenital pectus excavatum (ICD-10-CM Q67.6) from MDC 4 (Respiratory Conditions) to MDC 8 (Musculoskeletal and Connective Tissue Conditions) after receiving a request to align the MDCs of the corrective “Nuss” procedure (ICD-10-PCS 0PS0447, MDC 8) with the underlying medical conditions (ICD-10-CM Q67.6 “congenital pectus excavatum”, originally MDC 4; ICD-10-CM M95.4 “acquired pectus excavatum”, originally MDC 8).
By aligning all of the ICD-10-CM and ICD-10-PCS codes to MDC 8, there was a subsequent MS-DRG shift from 981-983 (Procedure Unrelated to Principal Diagnosis) to 515-517 (Other Musculoskeletal System and Connective Tissue O.R. procedures with MCC, with CC, and without CC/MCC, respectively) based on coding logic. This occurred because BOTH the medical and procedural Principal Diagnoses fell within the same MDC (08), which had NOT been true prior to CMS’s 2018 reassignment1.
At the University of Colorado Hospital, patients are regionally referred for the corrective “Nuss” procedure by a highly specialized Cardiothoracic Surgeon. For a Nuss procedure to correct pectus excavatum, there is deliberate entry into the pleural space as a planned aspect of the procedure. Post-operative pneumothoraces and chest-tubes are not infrequently part of the post-op course.
Problem
In 2020, the hospital’s Vizient Comprehensive Academic Medical Center Quality and Accountability Performance Scorecard demonstrated down trending from the year prior, and members of the Quality Department were asked to investigate. A review indicated that the primary area of opportunity was in “Safety,” which comprises 25% of the score. The Safety domain includes Patient Safety Indicators (PSIs) developed by the Agency for Healthcare and Research and Quality (AHRQ), NHSN Infection Surveillance and Laboratory ID Metrics, and the total hip and knee (THK) complication rate measure. The Clinical Quality Specialist (CQS) nurse identified PSI-06 Iatrogenic Pneumothorax metric performance (Z-Score) as specifically having undergone a significant negative change.
What the CQS learned about PSI-06 (Iatrogenic Pneumothorax) was that the relative rate per 1000 cases was quite low; which meant that a difference of just a few complications drastically affected the Z-Score, for better or worse. The CQS took a deep dive, performing chart reviews of each identified case, utilizing the AHRQ PSI Toolkit2. What was uncovered did not initially seem to make any sense: patients undergoing the Nuss surgery were showing up on the list. Review of the coding revealed a MS-DRG within the musculoskeletal and connective tissue MDC, instead of respiratory/thoracic.
Why would a surgery which is definitively a thoracic case – entering the chest cavity as part-and-parcel of the procedure3 – code to MSK/Connective Tissue? How could it not meet exclusion criteria for the PSI-06 metric?
Solutions
The hunt began, to answer these questions. Through asking the ‘how’ and the ‘why’, the CQS assembled a multidisciplinary team including a Cardiothoracic Surgery physician partner, Surgical service-line leadership, Quality, Clinical Documentation Integrity, and Coding. The team analyzed the Coding (which was correct), reviewed the Documentation (which was accurate, albeit did not specifically describe the clinical significance of the pneumothoraces, when present), and assessed the clinical utilization of resources (which were appropriate for the clinical condition). What was learned: a Nuss Principal Procedure (ICD-10-PCS 0PS0447) did not meet PSI-06 exclusion criteria because it was considered a corrective procedure for Diseases and Disorders of the Musculoskeletal System and Connective Tissue (ICD-10-CM Q67.6, MDC 8) and not a MDC 4 (Diseases and Disorders of the Respiratory System).
The team elicited that the 2018 CMS MDC code reassignment – while well-intentioned to align both the medical condition and surgical correction within the same MDC – had placed them within an MDC (08) which would not meet exclusion criteria for PSI-06 (such as surgical codes within MDC 4).
The following potential solutions were considered:
(1) Uniformly define pneumothorax as intrinsic to the procedure. This would prevent the need to code J95.811 and therefore not trigger PSI-06. The CDI Physician Advisor noted both the risk that documentation may not always indicate the integral relationship and the risk of under-documenting/under-coding clinically significant and/or unrelated pneumothoraces.
(2) Adopt post-operative clinical pathways to reduce potential overutilization of imaging (sp. CXR) which may incidentally diagnose clinically insignificant pneumothoraces. While the Cardiothoracic Surgeon supported limiting imaging to medically necessary situations, risk of under-recognition and potential clinical harm was identified.
(3) Advocate to CMS code reassignment for BOTH the relevant ICD-10-CM and ICD-10-PCS into MDC 4 (Respiratory Conditions), which would also have a subsequent MS-DRG change. The CDI and Coding Physician Advisors noted the recent, aforementioned code reassignment from 2018 and recognized that down-stream impact on complication metrics would likely be insufficient clinical basis upon which to request a national coding change, particularly with the fairly recent change placing both into MDC 4.
(4) Advocate to AHRQ the clinical basis for placing the Nuss procedure on the list of PSI-06 exclusion criteria, for the same reason all other thoracic surgeries are excluded.
Resolution
There are often numerous methods of tackling issues straddling as many realms as this one did. Sometimes, the easiest solution is the right one. Including robust description of the operative procedure by the Cardiothoracic Surgeon, this team chose (4) and presented the position to the AHRQ QI Technical Support Team.
The request was well received: “AHRQ understands that this procedure by definition includes thoracoscopy, pleural cavity entry, and insufflation of the pleural space. Accordingly, AHRQ is adding 0PS044Z and a substantial number of similar 0P codes involving open and thoracoscopic approaches to the THORAIP list, which will exclude these records from the denominator of PSI 06 in the v2021 software release.”
Conclusion
Bringing this full circle, was the coding wrong? No. Was documentation lacking? Not really. Were the metrics flawed? Well, since they followed the coding logic consistent with the reassignments made in 2018 and effectively identified secondary diagnosis codes not on the Denominator Exclusion list, the answer is debatably no. The provider’s predilection to instinctively disbelieve what the original data said about their Quality of care proved true – because metrics, like people, are imperfect and available for improvement. But after involving the provider in the process and empowering them to assert the clinical basis of a solution3, do you think they are more or less likely to trust that their voice will be heard the next time we call on them for quality improvement?
References
3. Nuss et al. Ann Cardiothorac Surg 2016;5(5):422-433.
Authors
John A. Updike M.D., M.P.H., F.A.C.P.
UCHealth Medical Director for Health Information Management & Coding
Instructor of Medicine
Division of Hospital Medicine
University of Colorado School of Medicine
LinkedIn: Drew Updike
Debra L. Anoff, M.D., F.H.M., F.A.C.P.
UCHealth Senior Medical Director of CDI
Associate Professor of Medicine
Division of Hospital Medicine
University of Colorado Denver, Anschutz Medical Campus
Alyson Dare Kelleher, B.S.N., R.N., CCRN-K
Clinical Quality Specialist in the Department of Clinical Quality and Patient Safety
University of Colorado Hospital in Aurora, CO
LinkedIn: Alyson Dare Kelleher
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American College of Physician Advisors
President's Corner
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As Dr. Hirsch mentioned at the top of the newsletter, Match Day was March 19th – the day we welcome into our respective specialties the newest crop of trainees who will soon be our colleagues. For physician advisors, these new doctors are individuals we will work with in the future on a possibly two-pronged basis.
First, for those physician advisors who continue to practice clinically, they will eventually share patients and call with these new graduates who will soon evolve into internal medicine or pediatric hospitalists, clinic-based family practitioners, general surgeons, radiologists, specialists in emergency medicine, and more. Gone are the days when physician advisors were assumed to be most effective if they had an internal medicine background. Time and time again we see subspecialists of all stripes effectively entering into the physician advisor fold, bringing their own unique perspectives and experiences into the mix. Similarly, hospitals and health systems are realizing that physician advisory services are not only required for adult patient populations. Increasingly, especially when it comes to challenges associated with commercial, Medicaid, and managed Medicaid payors, physician advisors with pediatric backgrounds are rapidly in demand.
Second, physician advisors working within academic hospital systems understand they are relied upon as potentially the foundation of knowledge involving hospital utilization, aspects of patient safety, optimal documentation, and continuity of care. While it seems medical schools are investing at least some time into instruction on these topics, clearly the majority of the focus (one could argue, rightfully so) is on the science of medicine and clinical care of patients. As such, it often falls on the hospital physician advisor to provide the lessons new residents must learn related to “the business of medicine” in its myriad of forms.
I think it’s safe to say the majority of us currently working as physician advisors have no recollection of learning, as a medical student or resident, about patient status, specificity of documentation for coding and billing purposes, or the merits of really thinking deliberately about which testing, imaging, or procedures are needed to take place before discharge vs. arranging for the outpatient setting. From my own history, it was my tenth and final year of practice as a pediatric hospitalist in 2013 when I first met with someone who had a title I’d never heard before – a “clinical documentation specialist” – to discuss how “urosepsis” should never be documented and “asthma exacerbation” needed more qualifiers about the type of asthma the child’s diagnosis entailed.
We are in a unique and frankly, exciting situation of finding ourselves as the tip of the spear. Few, if any of us, received as trainees the instruction we now routinely disseminate. How amazing it is to think we play a part in creating the future wave of clinicians who WILL enter their practice at least somewhat versed in the topics on which we focus? Our efforts and initiatives will carry on not only through the work of better-rounded clinicians but also, might light the spark to create future colleagues in our world of “physician advisordom.”
Sincerely,
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Juliet B. Ugarte Hopkins, MD, CHCQM-PHYADV
(Pronouns: She/Her)
President, ACPA
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The American College of Physician Advisors (ACPA) publishes and distributes materials created by our members and speakers for the benefit of all ACPA members. ACPA does not certify the accuracy or authority of these materials. These materials are distributed and presented as research information to be used by ACPA members, in conjunction with other research deemed necessary, in the exercise of ACPA members’ independent professional judgment. Original and fully-current sources of authority should be researched by ACPA members. ACPA disclaims all liability in relation to reliance on the content of these materials. The views expressed in the materials are the views of the material's authors and do not represent the views of ACPA. Any references are provided for informational purposes only and do not constitute endorsement of any sources. |
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