REP March 21

vol.29 no.3 • March 2021

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2021 Physician Fee Schedule Raises Smiles, Frowns, Among Doctors Some say the new rates will help doctors provide frontline care in their communities, while others believe the rates will ‘destabilize a healthcare system already under severe strain.’

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MARCH 2021 • VOLUME 29 • ISSUE 3

PUBLISHER’S LETTER Headed in the Right Direction...................................2

PHYSICIAN OFFICE LAB Colorectal Cancer Diagnostic Advances..................... 4

IDN OPPORTUNITIES

Dr. Ryan Stanton

Serving on the Front Lines Emergency physicians were tired, but determined, amid rising hospitalization rates and COVID cases............................. 8

SALES The Psychology of Selling When to leave your sales “child” at the office........................14

2021 Physician Fee Schedule Raises Smiles, Frowns, Among Doctors 18 HEALTHY REPS Health news and notes...............40

QUICK BYTES TRENDS

Technology news............................42

HIDA GOVERNMENT AFFAIRS A Thoughtful Approach to Pandemic Response Efforts.............................44

NEWS A Softer Stance on Physician Self-Referral and Kickbacks New rules mean that doctors and hospitals who coordinate patients’ care with other providers no longer face fines or prison......34

Industry news....................................50

Rep Corner

No Doubt About it Some people fall into supply chain management by accident. Katie Vincent jumped into it.

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repertoire magazine (ISSN 1520-7587) is published monthly by Share Moving Media, 1735 N. Brown Rd. Ste. 140, Lawrenceville, GA 30043-8153. Copyright 2021 by Share Moving Media. All rights reserved.

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PUBLISHER’S LETTER

Headed in the Right Direction After a year of things being completely upside down, we find ourselves back in March.

My last flight of 2020 was March 12. While in Nashville that week, I was at a restaurant with my best friend when a gentleman sitting across the bar from us was going on and on about the virus. He was scaring everyone at the bar and saying it would change the world forever. I finally had enough and asked him to please keep his thoughts to himself so we could enjoy dinner and a few drinks. It obviously aggravated him enough that he got up and left. As soon as he did, the bartender bought me a drink. “Thank you,” the bartender said, “he’s been here all week scaring everyone within earshot.”

Fast forward a year later and I’m here to say I was wrong – the virus certainly has changed the world. For those of us in healthcare sales, it’s changed our routines and sales cycles. What has been interesting to watch is how the different components of our industry have reacted and overcome the challenges of a year with COVID. As this year starts to unfold, I’m very optimistic that we will move closer and closer back to being who we are – a thriving, always pressing forward country full of opportunity and willing to help those less fortunate. For those of us here at Repertoire, I’m excited to report we’re off to a record start. This is what gives me enormous hope that our industry is headed in the right direction, with manufacturers investing in the channel and the channel consuming the content being created in order to deliver more value, efficiency, and products to those that need it the most, our front-line workers.

In closing I would compare 2020 to the Tampa Bay Buccaneers’ defense in the Super Bowl, and 2021 to Tom Brady delivering yet another GOAT offensive performance at the highest stage. We got through 2020 playing a lot of defense while we figured out how to solve our customers’ biggest problems. Now it’s time to go back on offense and start growing again.

Scott Adams

Hopefully, March 12 this year will be the first of many trips for us all.

Dedicated to the industry, R. Scott Adams PS: I’m not a Brady fan, but the Bucs’ D was something special to watch this year!

Repertoire is published monthly by Share Moving Media 1735 N. Brown Rd., Suite 140, Lawrenceville, GA 30043 Phone: (800) 536-5312, FAX: (770) 709-5432; e-mail: info@sharemovingmedia.com; www.sharemovingmedia.com

editorial staff editor

Mark Thill

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managing editor

vice president of sales

mthill@sharemovingmedia.com

Graham Garrison

Katie Educate

editor-in-chief, Dail-eNews

keducate@sharemovingmedia.com (800) 536.5312 x5271

ggarrison@sharemovingmedia.com

Alan Cherry

acherry@sharemovingmedia.com art director

publisher

Scott Adams

Brent Cashman

sadams@sharemovingmedia.com (800) 536.5312 x5256

circulation

founder

bcashman@sharemovingmedia.com

Laura Gantert

lgantert@sharemovingmedia.com

2

sales executive

Amy Cochran

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Brian Taylor

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2021 editorial board Richard Bigham: Atlantic Medical Solutions Eddie Dienes: McKesson Medical-Surgical Joan Eliasek: McKesson Medical-Surgical Ty Ford: Henry Schein Doug Harper: NDC Homecare Mark Kline: NDC Bob Ortiz: Medline Keith Boivin: IMCO Home Care

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PHYSICIAN OFFICE LAB

Colorectal Cancer Diagnostic Advances Few clinical conditions have been subject to the level of scrutiny of the effectiveness of

By Jim Poggi

screening as colorectal cancer. Numerous studies have shown that early detection can result in up to a 90% survival rate for stage I, but detection after the metastatic process has begun has a far worse prognosis, 11% for stage IV colon cancer.

Early cancer detection saves lives, reduces complications and reduces costs to the healthcare system and the patient. This is especially true of colorectal cancer, which the Centers for Disease Control and Prevention (CDC) describes as the third leading cause of death due to cancer in the United States. While CRC is still the third leading cause of cancer death in the United States, early detection has reduced its incidence from 79.2 cases per 100,000 in men in 1985 to 43.7 per 100,000 in men in 2013, a reduction of 45%. The incidence rate among women is lower (33/100,000 in 2013) and shows a similar decline from 57.3 cases per 100,000 in 1985. This reduction in incidence is due in the discovery and removal of precancerous polyps 4

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during diagnostic colonoscopy. However, the screening rate has plateaued at 65%.

Who recommends colorectal screening?

Early detection of cancer and detection of pre-cancerous states is a screening recommendation endorsed broadly by: ʯ American Cancer Society ʯ US Preventative Services Task Force ʯ American College of Gastroenterology ʯ American Medical Association ʯ Centers for Medicare and Medicaid Services ʯ MIPS measure #113 is colorectal cancer screening ʯ A variety of medical societies

While different medical societies use their own nomenclature, there are common threads involving which tests are most appropriate for detection of polyps and cancer. Stool tests (FOBT, FIT and FIT-DNA) are classified as cancer detection (American College of Gastroenterology) or “tests that find mainly cancer” (American Cancer Society) and are compared to direct visualization tests including colonoscopy, flexible sigmoidoscopy and CT/colonography which are classified as cancer prevention by American College of Gastroenterology

and “tests that find polyps and cancer” by American Cancer Society.

The following table is compiled from the most recent colorectal screening recommendations for each of the tests by each organization for patients at average risk for colorectal cancer. Current data shows a lifetime risk of colorectal cancer of 4.4% in men and 4.1% in women. Each society maintains a listing of exceptions for higher risk individuals and their high-risk patient data should be referenced for this information.

US Colorectal Screening Guidelines Summary from Leading Healthcare Associations Screening method

Defined as

By

Frequency

Guaiac fecal occult blood

Stool test

USPSTF

annual

Guaiac fecal occult blood

Tests that find mainly cancer

American Cancer Society

annual

Guaiac fecal occult blood

Cancer screening test

American College of Gastroenterology

Not recommended

FIT

Stool test

USPSTF

annual

FIT

Tests that find mainly cancer

American Cancer Society

annual

FIT

Cancer screening test

American College of Gastroenterology

Annual

FIT/DNA

Stool test

USPSTF

1 or 3 years

DNA

Tests that find mainly cancer

American Cancer Society

annual

DNA

Cancer screening test

American College of Gastroenterology

Every 3 years

Colonoscopy

Direct visualization test

USPSTF

Every 10 years

Colonoscopy

Tests that find cancer and polyps

American Cancer Society

Every 10 years

Colonoscopy

Tests that prevent cancer

American College of Gastroenterology

Every 10 years

Flexible sigmoidoscopy

Direct visualization test

USPSTF

Every 5 years

Flexible sigmoidoscopy

Tests that find cancer and polyps

American Cancer Society

Every 5 years

Flexible sigmoidoscopy

Colorectal cancer prevention

American College of Gastroenterology

Every 5-10 years

CT/colonography

Direct visualization

USPSTF

Every 5 years

CT/colonography

Tests that find polyps and cancer

American Cancer Society

Every 5 years

CT/colonography

Colorectal cancer prevention

American College of Gastroenterology

Every 5 years

mSEPT 9 DNA

Tests that prevent cancer

USPSTF

No Interval

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March 2021

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PHYSICIAN OFFICE LAB Colonoscopy

The new market entrants: Changing the game?

In the United States, colonoscopy is another screening method commonly performed to detect colorectal cancer. Done on an outpatient basis, once the patient has cleansed their colon using prescribed laxative agents, the test is performed with the patient under sedation, using a flexible tool that has a camera to visualize polyps and atypical tissue and a device to remove the tissue for examination and biopsy confirmation of whether it is cancerous or not.

Other imaging alternatives to visual methods include flexible sigmoidoscopy and CT/colonography.

FIT/DNA: In 2014, the FDA cleared a new test which, unlike previous tests, is performed in a reference lab setting, using the patient’s stool as a specimen. It is a combination of two different testing modalities. It uses both FIT and detection of both mutation and methylation of DNA found in the stool. The manufacturer claims the use of 11 different DNA markers in addition to detection of hemoglobin via FIT technology. A positive result is indicated by the presence of any of the DNA markers and/ or hemoglobin.

In common with earlier FOBT and FIT tests, it’s a take-home test requiring the patient to perform the stool collection at home and send back to be processed at the central lab. As such, it does not avoid the compliance issues inherent in the process. It’s recommended to be performed every three years as referenced above and claims a 92% sensitivity and 87% specificity compared to FIT results.

Early cancer detection saves lives, reduces complications and reduces costs to the healthcare system and the patient. This is especially true of colorectal cancer, which the CDC describes as the third leading cause of death due to cancer in the United States.

Fecal Immunochemical Testing (FIT) Around the world, beginning in the early 21st century and spearheaded by the Japanese healthcare system, newer fecal immunochemical testing methods began to be developed and introduced into the market. These tests promised a higher level of sensitivity and specificity to blood for improved screening outcomes. But, their cost per test was higher and sample collection issues persisted. Patient compliance was not substantially improved. While these tests are notably more sensitive than the guaiac methods, they are still subject to the vagaries of the disease process, including intermittent bleeding as well as lack of uniform presentation of blood throughout the stool.

Recent studies have also pointed out that the FIT tests while having a good level of sensitivity for the presence of blood from tumors are less effective at detecting polyps which are typically the first non-cancerous stage of tissue changes that lead to colorectal cancer.

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Blood test: A new CRC Dx option The most recently introduced screening test for colorectal cancer is a blood test. Unlike the other diagnostic tests, it stands alone in using a blood sample rather than a stool sample. The test is performed in reference laboratories and uses sophisticated real time PCR detection of methylated Septin 9 DNA which is indicative of colorectal cancer. Its sensitivity claim is ~70%% with specificity listed as ~80%.

There is a lot to know about “who to screen for what using what technology and how often” when it comes to colorectal cancer. That acknowledged, there are a few conclusions that can be made: ʯ The many different screening methods for colorectal cancer suit the broad range of patient conditions and preferences and are resulting in improvements in morbidity and mortality. ʯ Colorectal cancer screening WORKS. ʯ The healthcare community has developed clear guidelines regarding screening for colorectal cancer. ʯ The pace of technological change has advanced rapidly in the past 15 years and the healthcare community is receptive to these changes. ʯ New colorectal cancer markers are under development in universities and private companies and promise even better specificity in the future. ʯ Molecular techniques combined with blood samples rather than stool samples may pave the way for a higher level of patient compliance.

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IDN OPPORTUNITIES

Serving on the Front Lines Emergency physicians were tired, but determined, amid rising hospitalization rates and COVID cases.

Dr. Ryan Stanton, an emergency physician practicing in Kentucky, didn’t have to think long about what words he

would use to sum up how he feels after months of providing emergency care amid the COVID-19 pandemic.

Repertoire: Can you describe the toll that the pandemic has taken on emergency physicians and their departments? How has it affected their mental and physical health?

Dr. Ryan Stanton: I think everybody in medicine, but especially emergency medicine, is just tired now. Everybody is worn out. We can’t see each other’s faces, and everything’s very isolated. We can’t get together, we can’t do the things that we used to do for team building.

Then you’re especially nervous because a lot of folks outside the hospital feel like you’re always contagious.

So we have friends that haven’t been willing to talk to us since the onset because we’re in healthcare and they feel like we’re a Typhoid Mary, just waiting to spread COVID to everybody.

Then there were the initial frustrations with lack of PPE, or adequate PPE, when you’d start opening up masks and all the instructions are in Chinese.

And even now with the vaccine. Most that have access to it are overjoyed. But we’re hearing from places where it may not be getting to physicians in emergency conditions, emergency staff, front line folks. The logistics are tough, and trying to fight all the false narratives and conspiracies and everything that is out there is frustrating as well.

Dr. Ryan Stanton

“Fatigued and tired,” he said. “Everybody’s worn out.”

Indeed, the nation’s frontline caregivers have paid a physical, mental, and emotional toll in fighting the pandemic. Record-breaking hospitalization rates have taxed emergency physicians and emergency department staff in unprecedented ways. Dr. Stanton, a board member of the American College of Emergency Physicians (ACEP), talked to Repertoire about the challenges, and the repercussions for emergency departments and healthcare as a whole moving forward.

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Repertoire: What has COVID’s effect been on staffing shortages?

Dr. Stanton: The shortages are twofold.

In my situation, I started getting symptoms Thanksgiving week, so it was hard to get a test to confirm it. I had shifts coming up, so I was worried about getting those shifts covered. Thankfully for me it went very smoothly.

But for the nursing situation, you have exposures, people are out and of course the changing amount of time that it’s going to be – whether it’s 10 days, 14 days, etc., A lot of hospitals and facilities have models where even with exposure you still work unless you develop symptoms, because some people were taking advantage of it.

When we had our numbers drop in March, a lot of hospitals cut their staff. So in March and April, the workforce numbers were down, and they’re still down in some places. They cut their staffs, but like everything does, volumes came back. We’re about 90% to 95% of our volume, but we still haven’t been able to hire back or find the folks to fully staff the ER and hospital again. Then you have those that transitioned to traveling nursing gigs and things like that.

So it’s been a real challenge not only with the virus itself, but with the workforce numbers that came during this unexpected drop in volume, and then the rebound.

Repertoire: How are hospitals and health systems trying to help in these areas from an organizational standpoint?

Dr. Stanton: There are very lucrative opportunities in hard hit areas that promote transition to travel nursing opportunities. This poses a challenge for staffing in community and rural settings.

Hospitals are trying to hire, but you can’t just flip a switch on staff and hire somebody and have them in.

You have to onboard. Almost all nurses in the emergency department, whenever they’re hired, they’re precepted for at least a couple of weeks, if not longer (especially if they’re a new nurse) to get used to the system, to get used to our emergency department. So it takes quite a while to get the numbers back up. And during that time, you may lose a few more. Hospitals are trying their best, it’s just that there’s a limited commodity, and everybody’s looking right now.

Repertoire: What’s the communication between the emergency departments and supply chain been like as far as trying to get the necessary PPE, medical supplies and adjusting to the new demand?

Dr. Stanton: The biggest thing with that is whether your C suite – the part of the hospital that has carpeted offices – is connected to emergency medicine. Is there physician leadership that understands emergency medicine, or is ita disconnected?

A lot of places see the entire healthcare setting as one entity, and don’t understand the unique environment of the emergency department. Thus understanding the flow, speed, turnover, acuity and everything else involved with it. The closer that the administration was with emergency medicine and frontline health, the better the process was.

For instance, knowing that we can’t say we’re not going to wear N95s until we have high suspicion that somebody has COVID. We learned that our first COVID patient didn’t come in with COVID symptoms, the patient came in with a stroke. So everybody was in the CT scanner room with no PPE on. That was before we understood the nature of COVID. We learned we have to wear PPE for COVID in every single room.

So getting those understandings, and understanding when the volumes are going to come, and when they’re not going to come. Now in the winter with the amount of COVID cases, bed space is an issue. I have a friend that posted last week that he has a 20-bed emergency department and they had 34 boarders in the emergency department, so they had more people admitted to the hospital in the ER than there were beds. One of those boarders had been there 15 days.

There are very lucrative opportunities in hard hit areas that promote transition to travel nursing opportunities.

This poses a challenge for staffing in community and rural settings.

Communication has to be evolving. What you established in March is not going to work now. Currently one of the biggest things with the communication is on the vaccine. Who gets it, and understanding who are the highest risk exposures. At first, our system didn’t put our treatment center on the first round of vaccines. But that’s our second line where we’re sending our COVID patients, they’re the primary care offices in a community, and so they have very high risk of exposure. Understanding your whole landscape is very important. And I think different places have done better, some have done worse, and everything in between.

Repertoire: What are some long-term implications of the pandemic for emergency departments?

Dr. Stanton: I think it’s going to change the face and practice of medicine overall, because I think we’ve figured out www.repertoiremag.com

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March 2021

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IDN OPPORTUNITIES some things that we’ve been doing wrong, but we’ve never been in a situation where we get the risk associated with it.

With supply chain, we’ve been very satisfied with just-in-time delivery and lean processes for the last 20 years. But that doesn’t work when you have a pandemic.

You can’t have just-in-time delivery, because nobody can deliver. I think we’ve learned a lot of stuff about when we are prosperous, we may be putting ourselves in a position of risk. Over the last 20 years, we’ve been very prosperous in terms of having stuff at our fingertips, being able to order something and have it in house later that day, whatever it may be. And that works until there’s a pandemic or a big disaster. That puts a lot of people, including our healthcare folks, at risk.

The average emergency physician sees about 20,000 patients before they’re considered sufficiently competent in emergency medicine.

We typically have 20,000 hours of training before we can be board certified.

From a workforce standpoint, I think we’re going to see significant attrition after the pandemic, with physicians, nurses, and techs wanting to get out of health care.

The message they’re hearing is, “Thank you for serving on the front lines of the pandemic, now we’re going to cut your pay and benefits.” With that going on and then what’s happening with Medicare and insurance, I think you’re going to see a fair amount of attrition and turnover, which could make access to care even more difficult moving forward.

Repertoire: Are organizations anticipating the attrition and trying to work toward preventing it?

Dr. Stanton: I think some are. While I think you’ll be able to make up with bodies, the question is quality.

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There is a big difference between having a board certified emergency physician versus a nurse practitioner that just finished their online degree. Though they are both providers, the quality is going to be very different, the experience is very different. There are mechanisms by which to replace, but the question is, what is the experience and knowledge and what’s being lost from a patient exposure standpoint?

The average emergency physician sees about 20,000 patients before they’re considered sufficiently competent in emergency medicine. We typically have 20,000 hours of training before we can be board certified. When we replace, when we backfill, what’s the loss because of that?

I think a lot of facilities are trying to put plans of succession and future growth and pipelines to staffing models.

But again, there’s a shifting landscape of where are your people? What are their degrees and qualifications? And what’s the demand out there?

The challenge now is that we have a whole country that’s going to be dealing with supply and demand, as opposed to just regional stuff, which is just easy to fix with people moving from site to site to get a better job, better facilities, better support. But now it’s the whole country.

Repertoire: What do the next few months look like for emergency physicians?

Dr. Stanton: The biggest thing that has uplifted medicine, especially emergency physicians and emergency staff, has been the vaccine. The vaccine was the first time in nine months that we’ve seen frontline health care workers with a positive outlook on the pandemic and that there’s going to be an end. Before it seemed like the goalposts were moving farther and farther away. Everybody is finally upbeat with seeing the potential light at the end of the tunnel.

Also, there have been some side benefits. I’ve not seen a single flu case so far this year. We aren’t seeing RSV, we’re not seeing norovirus, we’re not seeing the usual things this time of year. So there’s been a benefit from those standpoints. Those tend to be high risk for our young children, so our children are probably safer this winter than they’ve ever been.

We’re looking forward to 2021 being an exit strategy to the pandemic. We’re starting to see a change in the mood towards more positive now than what we would have seen a month ago. And I think that’s going to continue as we see the numbers start to drop off in mid-January, which is expected after the holidays. They’ll shoot up a little bit and then start to tail off, and hopefully with the vaccine distribution, we’ll see it go away for good.

SALES

The Psychology of Selling When to leave your sales “child” at the office

By Sandler Systems, the nation’s leading resource for sales training Transactional Analysis, or TA, is the human relationship based selling model built upon and around the premise

that each one of us, through no fault or effort of our own, is actually three people in one: ʯ The Child we once were ʯ A “copy” of the Parent or other authority figure we observed when we were that child ʯ An objective, analytical and logical Adult processor of data

games, act selfishly, or seek approval. The Child should play no part in the interaction between you and your prospect.

You might be thinking that’s obvious, but it’s easier said than done! Read on for ways that our Child can sneak into conversations and meetings without your permission!

The Parent

Each of these figures represents one aspect of our “ego state,” referred to as the Child, the Parent and the Adult. David Sandler, the mastermind behind Sandler Systems, was able to develop strategies to not only recognize these ego states as they relate to sales, but also to explain and adapt appropriate ego state-directed behavior specifically to the selling arena.

The Parent ego state actually has two components; the Critical Parent and the Nurturing Parent. When dealing with prospects, your most productive behavior is your Nurturing Parent. Your messages and conversation should take on the qualities of warmth, friendliness and support. Statements like, “I can feel your frustration,” or “I’d feel the same way if I were in your shoes,” get better responses than, “Don’t let that bother you, it’s not important,” or “That wouldn’t bother me.” Telling the prospect what to do or how to do it is the Critical Parent talking, and that will turn a prospect off.

A good balance to keep in mind is that your Nurturing Parent ego state should direct 70% of the interactions with your prospects.

The Adult The Child The Child ego state is a permanent record of your internal responses to external experiences that occurred during the first five years of your life. While your Parent ego was recording what to do, what to say, and how to act, your Child ego was recording how you felt, your instincts, intuition and sense of physical self.

One Sandler Rule is, “People make buying decisions emotionally. They only justify their decisions intellectually.” The Child makes that emotional decision of “I want it” or “I don’t want it.” Your Child ego should be left at the office! The selling process is not the time to play 14

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The Adult ego state should direct the other 30% of your interactions with prospects. Adult-directed communications are intellectual, i.e., rational and logical statements of fact and evaluation of data.

So how can knowing about ego states improve your interactions with prospects?

If you have an Adult understanding with the prospect whereby you can ask questions and share information, you can engage the prospect’s Child to uncover the reasons for doing business. Meanwhile, the prospect’s Parent watches the process and keeps you from overwhelming the Child and getting a

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SALES premature decision. The prospect’s Parent gives the Child permission to buy the product or service. The prospect’s Adult can then evaluate the facts and make the decision.

Would it help to go back and read that paragraph again? Transactional Analysis is fascinating in action – but it takes a little practice to “watch” it happen when you’re on the inside of a sale.

One of the benefits of By making a the Sandler System is the skill conscious choice to recognize the prospect’s to leave your ego states as well as your own Child out of the and act accordingly, calling discussion, you on the appropriate behavcan re-engage, reassess iors of your own ego states and reclaim to influence theirs. The result momentum in is positive interactions with the discussion. both prospects and clients!

Transactional analysis in action – when under attack, fall back Let’s look at an example of TA in action …

Has this ever happened to you? You’re in the middle of a discussion with a prospect, and suddenly you’re caught unaware by what feels like a personal attack.

Maybe the prospect says something like, “You obviously don’t know a whole lot about our industry,” or “This presentation has no relevance to what you and I talked about.” Or maybe you pick up a sudden, distinctly negative body language signal, like the prospect shaking his head slowly back and forth or a skeptical set of her jaw.

And then what happens? You fight back. Without much thought, and driven by barely suppressed emotion, you react immediately!

Perhaps you say, “On the contrary, I did a lot of indepth research on your industry,” or, “Actually, I took very detailed notes during our previous conversation, and this presentation/demonstration is based exclusively on those notes. Here, I can show you.” Or worst of all, “What’s that supposed to mean?”

These are all emotional reactions. No matter how “right” you may happen to be in your instant rebuttal, it’s a good bet that you will lose the sale, and damage the relationship, by reacting in this way.

So what’s really happening here?

This is Transactional Analysis in action. In this example, you can probably identify from which ego state the salesperson and the prospect are operating: nurturing or critical Parent, detached Adult or emotional Child. This is how we’re wired. When the prospect made that comment or sent that negative body language signal, he or she was, in all likelihood, responding from the Child ego state.

While it’s important to avoid triggering negative Child responses from your prospects, it’s even more important to suppress your own Child reactions to the things your prospects say or do!

The next time you get this kind of feedback from a prospect, step back and make a conscious effort to leave your own Child out of the discussion. When you’re under attack, fall back!

The best way to do this is simply to take a deep breath and remind yourself that while it’s normal to ask yourself what you did “wrong,” a far more constructive question to ask is, “What’s wrong with the prospect?”

By focusing on the prospect, rather than reacting from your own Child Ego State, you can comment or ask questions from an Adult or Nurturing Parent position. This allows you to explore the motivation for the prospect’s action. For instance: “Bill, what is it that I’ve said that makes you doubt my research?”

“Mary, what is it specifically about my presentation that isn’t working for you?”

Or simply: “I suspect that what I’ve presented thus far is not what you were hoping for.” (Then stop talking.)

By making a conscious choice to leave your Child out of the discussion, you can re-engage, reassess and reclaim momentum in the discussion. You’ll identify what really triggered the negative response. You’ll stand a much better chance of sustaining a positive business relationship with this person … and, eventually, closing the deal.

Interested in learning more about how to achieve success – both professionally and personally? To schedule a complimentary 30-minute advisory session on transactional analysis, a formula for success, or other sales or sales management challenges, send your request and contact information to SalesTips@repertoiremag.com with “Free Consultation” in the subject line.

About Sandler Training With over 250 local training centers around the globe, Sandler is the worldwide leader for sales, management, and customer service training. We help individuals and teams from Fortune 500 companies to independent producers dramatically improve sales, while reducing operational and leadership friction. © 2021 Sandler Systems, Inc. All rights reserved.

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2021 Physician Fee Schedule Raises Smiles, Frowns, Among Doctors Some say the new rates will help doctors provide frontline care in their communities, while others believe the rates will ‘destabilize a healthcare system already under severe strain.’

Primary care physicians are pleased they will be rewarded

for the time and energy spent on evaluating and managing their patients, especially those with chronic conditions, per the 2021 Medicare Physician Fee Schedule (PFS), which became effective Jan. 1. But doctors who bill more surgical and procedural services and fewer E/M services have less to smile about.

The Centers for Medicare & Medicaid Services says the new fee schedule reflects the agency’s investment in primary care and chronic disease management and will cut some of the red tape traditionally associated with reimbursement. The rule also addresses telehealth and remote patient monitoring, and nails down new responsibilities for non-physician practitioners. www.repertoiremag.com

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2021 Physician Fee Schedule Overview

“We need to ensure that practices across the country are able to continue to operate and provide frontline care in their communities.”

Under the schedule, some physiproposed payment cuts would harm cian specialties will likely see a rise in patients by forcing doctors to make Medicare reimbursement, including extremely difficult decisions, such as endocrinology, rheumatology, family reducing Medicare patient intake, laypractice and hematology/oncology. ing off nurses and administrative staff, Other specialties, including anestheand delaying investment in technology. sia, emergency and surgery, won’t.

Since 1992, Medicare has paid “The payment improvements for the services of physicians and will go a long way to helping physiother billing professionals under the cian practices over the next year as Physician Fee Schedule. Payments we continue to deal with COVID-19, are based on the relative resources and in the future,” said Jacqueline W. typically used to furnish the serFincher, M.D., MACP, president of vice. Relative value units (RVUs) are – Jacqueline W. Fincher, M.D., MACP, the American College of Physicians, in applied to each service for physician president, American College of Physicians a statement issued on Dec. 2, one day work, practice expense, and malpracafter CMS released the final schedtice. These RVUs become payment ule. “We need to ensure that practices across the country rates through the application of a conversion factor. Payare able to continue to operate and provide frontline care ment rates are calculated to include an overall payment in their communities.” update specified by statute.

On the other hand, the American College of Surgeons To account for the increase in RVUs for E/M sersaid the new fee schedule “will harm patients and furvices and still maintain compliance with a budget neuther destabilize a healthcare system already under severe trality adjustment, CMS decreased the 2021 conversion strain from the COVID-19 pandemic.” The organization factor to $34.89, down $1.20 from the previous year’s said that a survey it conducted in September showed that conversion factor of $36.09.

Projected winners, losers from 2021 Medicare Physician Fee Schedule Winners Specialty

Losers Impact

Specialty

Somewhere in between Impact

Specialty

Endocrinology

14%

Anesthesiology

-1%

Obstetrics/gynecology

7%

Rheumatology

13%

Vascular surgery

-1%

Pediatrics

7%

Hematology/oncology

12%

Cardiac surgery

-2%

Internal medicine

6%

Family medicine

12%

Chiropractor

-2%

Geriatrics

6%

Nephrology

11%

Interventional radiology

-2%

Otolaryngology

6%

Clinical social worker

9%

Physical/occupational therapy

-2%

Podiatry

6%

Physician assistant

9%

Pathology

-2%

Dermatology

5%

Nurse practitioner

9%

Radiology

-3%

Cardiology

4%

General practice

8%

Nurse anesthetist/assistant

-3%

Pulmonary disease

4%

Psychiatry

8%

Gastroenterology

2%

Interventional pain mgmt.

8%

General surgery

0%

Clinical psychologist

8%

Allergy/immunology

8%

Urology

8%

Source: American Medical Association. (For a complete list of specialties, see: American Medical Association)

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2021 Physician Fee Schedule and Your Customers

Evaluation and Management

Primary Care Doctors Fare OK Under New Fee Schedule Evaluation-and-management services will be rewarded Primary care physicians generally are pleased with the 2021 Medicare Physician Fee Schedule, as reimbursement

for office-based evaluation and management (E/M) services will increase this year. So will the value of many bundled services, such as maternity services and transitional care management. What’s more, the new fee schedule means primary care doctors should experience less red tape and “note bloat” when seeking reimbursement.

“What will this mean for physicians who see patients in the office?” asked Kathy Blake, M.D., MPH, vice president, Health Care Quality, for the American Medical Association, at a virtual panel in mid-December. “We’re expecting you’ll be able to spend more time with patients and less time on documentation and coding. And really, the hope is that we can correct the current imbalance, which is that for every hour physicians spend with a patient, they spend two hours behind a computer screen.”

Two choices The final rule simplifies coding for E/M services, so that physician practices can code based either on medical decision-making or total time.

Prior to this, E/M codes were dependent on the physician evaluating the chief complaint, history of present illness, review of physiological systems, and past, family and social history, says Lisa Satterfield, senior director, health economics and practice management, for the American College of Obstetricians and Gynecologists. “These requirements were not clinically applicable to all patients and required significant documentation.

Now physicians can choose between the total time caring for the patient on the date of service, which includes the review of records and documentation from other providers, or the complexity of the patient. The changes allow the physician to focus on the patient and their clinical needs, and removes the check-box-like system.”

AMA President Susan R. Bailey, M.D., told Repertoire, “The process for coding and documenting E/M office visit services is now simpler and more flexible. It has been estimated that the new E/M coding and documentation guidelines for office visits will save clinicians 2.3 million hours per year.”

Family physicians Kent Moore, senior strategist for physician payment, American Academy of Family Physicians, calls the changes to the office/outpatient visit 22

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2021 Physician Fee Schedule and Your Customers

Evaluation and Management

E/M codes “the most significant since the codes were implemented in 1992.

“Prior to the new rule, physicians could only code based on time if counseling and/or coordination of care dominated the encounter, that is, consumed more than half of the physician’s face-to-face time with the patient,” says Moore.

Now, physicians can code based on total time spent on the date of service, including time spent before and after the visit, he says. “The significance of coding office visits based either on medical decision-making [MDM] or total time is that physicians have only one element – MDM or total time – to consider when selecting a level service, [instead of] three elements (history, exam, and MDM). How all of this will influence physicians’ behavior remains to be seen.”

‘ Now payment is aligning with how physicians are practicing.’

CMS had initially proposed implementing a primary care add-on code (G2211) for complexity. But in December, Congress put off implementing the code for three years, in order to make an adjustment to the overall Medicare conversion factor.

The decision disappointed AAFP, says Moore.

“CMS estimated that physicians who rely on office visit E/M codes, such as family physicians, would have used G2211 with 90% of visits. The payment associated with G2211 would have helped support family physicians and other primary care physicians in their efforts to meet the needs of their patient populations. For the patients of AAFP members, the delay in implementation of G2211 is neither good nor bad news in most cases, because AAFP members will continue to provide the same high standard of care to those patients, regardless. It will just be harder to do so without the support that G2211 would have otherwise provided.”

Patient-focused “We anticipate that many obstetrician-gynecologists will appreciate the change of the codes being patient-focused, 24

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and will likely use the medical decision-making algorithm when seeing their patients,” says Satterfield. That algorithm takes into account three things: patient complexity, the amount and complexity of the data the physician must review in order to determine a proper course of treatment, and the risk of treatment or lack thereof.

Prior to the new rule, decision-making was based in part on how many physiological systems – e.g., neurological, circulatory, etc. – the physician reviewed, in addition to a history and physical. “It was based on what the physician did and not how the patient presented,” says Satterfield. “Now payment is aligning with how physicians are practicing.”

ACOG takes exception to a few provisions of the 2021 fee schedule. “Because of some technicalities in statute, CMS determined they could not update the post-surgical visits bundled into the surgical codes. That decision, along with the overestimation of G2211, results in a significant decrease for all physicians, and especially surgical services. Gynecologic surgeries are necessary and important to women’s healthcare.

“While Congress temporarily mitigated some of the significant cuts in payment through the recent COVID relief bill, most physicians are going to see approximately 5% decrease in overall payment for Medicare patients in 2021,” Satterfield says. “The effects are even more detrimental to those who provide services for beneficiaries of the Medicaid program, where the average payment is about 68% of Medicare rates. These cuts are occurring when obstetrician-gynecologists are providing care to women across the lifespan and making accommodations in their practices to minimize their patients’ exposure to COVID.” Like ACOG, the American Medical Association takes exception to a few E/M provisions of the 2021 final rule.

Last fall, the AMA had recommended that CMS incorporate increases of reimbursement for office visits into surgical global payments. The final rule does not include that provision.

“Medicare and many other payors do not allow physicians to report hospital and office visits that occur in the post-operative payment,” says Bailey. “For a major surgical procedure, all visits performed for 90 days following the surgery are considered bundled into the payment for the surgery. Historically, when hospitals or office visits have increased, the payment for these visits within the bundle has also increased. The AMA, the RUC [RVS Update Committee], and numerous national medical specialty societies continue to call on CMS to fairly increase the payment for these visits incorporated into the surgical global payments.”

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2021 Physician Fee Schedule and Your Customers

Nurse Practitioners and Physician Assistants

Expanded Role for NPs and PAs in Diagnostic Testing Nurse practitioners, physician assistants, clinical nurse specialists and certified nurse-midwives have the green

light to supervise the performance of diagnostic tests even after the COVID-19 public health emergency has ended, per the 2021 Medicare Physician Fee Schedule. This makes permanent a temporary provision in place since May 2021.

“This is a significant change from CMS that better aligns Medicare coverage policy for diagnostic tests with the state scope of practice of nurse practitioners,” says Nancy McMurrey, vice president of communications, American Association of Nurse Practitioners.

“This policy was initially implemented for the duration of the COVID-19 Public Health Emergency (PHE), and it improved patient access to testing … at a time when this was much needed in their communities. Making this policy permanent will continue this expanded access to diagnostic testing for Medicare patients.”

Michael Powe, vice president of reimbursement and professional advocacy for the American Academy of Physician Assistants, called CMS’ decision “an important step in removing a regulatory barrier that previously hindered the ability of PAs and NPs to practice medicine efficiently. With the looming shortage of physicians and the need to increase patient access to care, it is imperative 26

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that PAs and other health professionals practice to the top of their education and competency.”

Lab expert Jim Poggi, Tested Insights, LLC, says the new schedule “expands the number of individuals who can order COVID tests beyond the traditional boundaries; allows patient-directed testing, permitting patients to perform sample collection at home and send the sample to a laboratory; and also permits a wider range of acceptable testing locations, including drive-through and popup testing sites.” It also applies to tests for influenza and RSV, and will make differential diagnosis of respiratory infection more comprehensive and timely, he says.

Expand accessibility of testing Prior to the waiver (and ultimately the final rule), if Medicare required clinician orders for coverage of a diagnostic test, nurse practitioners could complete those orders and Medicare would cover the test, says McMurrey. NPs were

also authorized to perform diagnostic tests and have those tests covered by Medicare. “However, prior to this rule change, if another member of the clinical staff – for example, a registered nurse – performed the test, that clinical staff member would have to be under the general supervision of a physician in order for Medicare to cover the test.

Now, with the rule change, an NP is authorized to supervise the clinical staff member and have the test covered by Medicare. This is a new Medicare policy, but this is consistent with state policies that were already in effect.

“It will expand the accessibility for patients, improve efficiencies for Medicare patients, and allow practices – including those owned by nurse practitioners, long-termcare facilities and other settings – to utilize their clinical staff to a fuller extent.”

‘ It permits a wider range of acceptable testing locations, including drivethrough and pop-up testing sites.’

Says Powe, “Previously, for certain diagnostic tests, there was a requirement for a physician to be physically onsite to meet Medicare’s supervision requirements. Under the old rules, if a physician left the office to round at the hospital, for example, and a patient came in for a visit and needed a certain diagnostic test, the test might not be able to be performed if a PA was present in the office. The patient might be forced to return on a different day to have the test performed. With the new regulation authorizing PAs to supervise diagnostic tests, that same patient could receive the test on the same day as their office visit, avoiding an additional visit to the practice.”

Poggi believes the final rule should serve as a reminder to Repertoire readers that they should routinely inform all their clinicians of the importance of lab testing and remind them of the product portfolio available to them through their companies. “Within the complex decision-making process of larger group practices, it is always wise to consult the office manager or lab director before approaching other members of the clinical staff to assure they know and understand your approach.”

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2021 Physician Fee Schedule and Your Customers

Remote Physiologic Monitoring

Remote Patient Monitoring Endorsed by Medicare “It is encouraging to see CMS fully embrace next generation technologies within traditional healthcare,” says

Thomas D. Schwieterman, M.D., vice president of clinical affairs and CMO for Midmark, characterizing Medicare’s expansion of remote physiologic monitoring in the 2021 Physician Fee Schedule. “I feel it has the potential to advance care delivery.”

In the new fee schedule, which became effective Jan. 1, CMS clarified its payment policies related to remote physiologic monitoring (RPM), and made permanent two modifications that were established in response to the COVID-19 public health emergency. Among other provisions, CMS: ʯ Clarified that after the COVID-19 public health emergency, there must be an established patient-physician relationship for RPM services to be furnished. ʯ Clarified that the medical device supplied to a patient as part of RPM services must be a medical device as defined by the Federal Food, Drug, and Cosmetic Act; that the device must be reliable and valid; and that the data be electronically (i.e., automatically) collected and transmitted rather than self-reported. ʯ Clarified that only physicians and non-physician providers who are eligible to furnish evaluation and management (E/M) services may bill RPM services.

Full endorsement “What is significant, in my mind, is the fact that, with these breakthrough policies, CMS has fully endorsed visits and care that are not face-to-face,” says Schwieterman. “Since the original charter in 1965, the requirement that billable 28

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services largely occur at designated points of care has been a staple of how reimbursement is governed at CMS. “No longer can we simply look at established venues like hospitals, surgery centers, extended care, ambulatory care, and urgent care. The home is now ‘in play,’ and companies that participate in chronic disease care, and acute care for that matter, will need to have effective answers, if not solutions, that incorporate distributed care ‘everywhere.’”

Schwieterman credits COVID-19 with breaking the logjam that has slowed acceptance of remote physiologic monitoring. Prior to the public health emergency, even though the technology and the patients were ready, providers were skeptical of its medical value and just as skeptical of their ability to get reimbursed for offering the service.

Meanwhile, payers were spooked by the potential for heavy abuse of the privilege. “The COVID-19 pilot lowered the fear level on the part of all three stakeholders,” he says.

‘With these breakthrough policies, CMS has fully endorsed visits and care that are not face-to-face.’

But the need for technology-enabled care – care that is more continuous, asynchronous and virtual – arose long before COVID-19. “It arose mainly because of the rapid acceleration of value-based care and the growing awareness that patients achieve better outcomes at lower cost when their care management is more rigorous and continuous.”

Schwieterman feels that much of the causation of chronic disease, and similarly the poor outcomes for those with chronic disease, stem from poor decision-making

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2021 Physician Fee Schedule and Your Customers

Remote Physiologic Monitoring

by patients and an inability to change unhealthy lifestyles and habits. Remote patient management can directly address both.

What’s more, clinical standards are increasingly calling for at-home physiologic measures. “Diabetes has a very long track record of home monitoring with low-cost glucose meters. The technology is getting better every year, with new platforms that not only record the sugar levels, but also offer insights and behavior modification to improve diabetic control.”

“Recently, the American Heart Association, along with the American Medical Association, American College of Cardiology and others, have advocated for home blood pressure as a validation path to diagnose and manage hypertension. The list of chronic diseases that use at-home sensors is destined to grow as payers target reimbursement payments (incentives) to reward care teams that reduce cost and lower patient morbidity.”

‘Virtual care is here to stay’ Remote monitoring has great potential for helping patients effectively manage their chronic conditions, allowing physicians to intervene earlier to improve patient outcomes and decrease healthcare costs, says Steven Waldren, M.D., vice president and chief medical informatics officer for the American Academy of Family Physicians.

What’s more, the fact that the 2021 fee schedule opened the door for remote monitoring for patients with acute conditions – not simply chronic care management – is another good sign. “CMS is saying, ‘We think virtual care is here to stay, and there are multiple ways to apply it.’”

CMS’ insistence that an established patient-physician relationship be in place for RPM services will help limit fraud and abuse and help ensure that any remote monitoring is coordinated with the patient’s usual source of care, says Waldren. “As we see further expansion of virtual services after the public health emergency, it is in the best interest of patients that those services are coordinated and continuous with their longitudinal care. Also it is much more likely that downstream costs – the costs of the virtual service – will be higher if that virtual service is not part of a patient’s comprehensive primary care.”

The final rule’s stipulation that remote monitoring data be electronically – that is, automatically – collected and transmitted rather than self-reported could present some challenges, he continues. “A concern is the lack of standards and conventions in place for RPM devices to 30

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electronically transmit. It is likely that at least each manufacturer may have its own custom approach to transmitting the data. This is likely to dramatically increase the administrative burden on practices and make data integration into the EHR difficult.

“Nor will manufacturers consider how the data streams from these devices should be analyzed to provide physicians and practices with actionable dashboards.

It could be a logistical nightmare for a practice if they are getting raw data streaming into the practice, as practice staff will likely have to log into multiple portals to access the streams. What is needed is smart software, which can provide appropriate alerting and creation of patient- and population-appropriate dashboards.”

‘ A concern is the lack of standards and conventions in place for RPM devices to electronically transmit.’

No substitute These new physician payment rules will open doors to innovation, says Schwieterman. But they will not replace traditional care. “When behavior modification is a central theme to improving outcomes, a relationship with a trusted clinician is a logical predecessor. Remote banking did not replace your bank or your banker; it just made banking more convenient. The established doctor-patient relationship remains a central theme and will be for many years to come. CMS understands this; hence, the rule set we see here.

“CMS needs to be credited with their remarkably swift action on clarifying the rules, especially during the chaos and financial crisis brought on by a global pandemic. But, like any governmental action, the road is certain to be bumpy and curvy. Undoubtedly there will be new twists and turns for years to come as this new means of care gets fully integrated into the lexicon. Providers can expect a few false starts, some unexpected surprises – both good and bad – and frequent revisions.”

2021 Physician Fee Schedule and Your Customers

Telehealth

Telehealth Expansion is Part of 2021 Fee Schedule What COVID-19 kick-started, the Centers for Medicare & Medicaid Services endorsed in the 2021 Medicare

Physician Fee Schedule, adding a list of reimbursable telehealth services.

“The American College of Physicians is pleased that CMS has made the expansion of telehealth a priority in the physician fee schedule,” says Brian Outland, the College’s director of regulatory affairs. “The flexibilities that were put in place earlier in the COVID-19 pandemic have been important for patients to access care, and important for physicians to keep their practices open and operating. Many physician practices have faced dire financial situations while we have been dealing with the COVID-19 pandemic. While telehealth visits won’t make up for that entirely, they do help to keep practices open and help patients who would avoid in-person visits to access care.”

Before the COVID-19 public health emergency (PHE), only 15,000 fee-for-service beneficiaries each week received a Medicare telemedicine service, according to CMS. Under a special waiver for the PHE in March 2021, Medicare was authorized to pay for office, hospital, and other visits furnished via telehealth, including those originating in patients’ places of residence. Preliminary data shows that between mid-March and mid-October 32

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2021, over 24.5 million out of 63 million beneficiaries and enrollees received a Medicare telemedicine service.

Services added to the Medicare telehealth list in the 2021 Physician Fee Schedule include “domiciliary, rest home or custodial care services,” home visits with established patients, “cognitive assessment and care planning services,” and “visit complexity inherent to certain office/outpatient evaluation and management (E/M).”

Additionally, CMS created a temporary category of criteria – called Category 3 – for services added to the Medicare telehealth list during the public health emergency that will remain on the list through the calendar year in which the PHE ends.

Despite some disappointment around CMS’ decisions regarding remote patient monitoring, the American Telemedicine Association believes that overall, the final rule is a positive step, says Kyle Zebley, director of public policy. “CMS has gone out of its way to think creatively.” Still, some roadblocks to fuller implementation of telehealth exist, he says.

For example, CMS lacks the authority to permanently permit reimbursement for home-based telehealth. “As it stands, you have to be at a provider’s location in order to have reimbursable telehealth,” says Zebley. “That is an outdated law written decades ago, and it needs to be changed.” But only Congress, through legislation, can make that happen. Likewise, only Congress can change existing law that (but for the public health emergency) restricts reimbursable telehealth services to patients in defined rural geographic locations, he says. “Of course, we believe telehealth should be available to those in rural areas, but we also think the law should cover telehealth services for Medicare recipients no matter where they live.”

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TRENDS

A Softer Stance on Physician Self-Referral and Kickbacks New rules mean that doctors and hospitals who coordinate patients’ care with other providers no longer face fines or prison In 1972, the federal anti-kickback statute prohibited paying for or receiving any remuneration in return for Medi-

care- or Medicaid-funded business. Seventeen years later, in 1989, doctors were prohibited – by the Stark Law – from making referrals for healthcare services to entities in which they had a financial relationship. The two statutes were intended to reduce fraud and waste, but over the years, the industry questioned whether they were counterproductive to efforts that encouraged value-based arrangements instead of the traditional fee-for-service.

“Industry stakeholders informed us that, because the consequences of noncompliance with the physician self-referral law (and the anti-kickback statute) are so dire, providers, suppliers, and physicians may be discouraged from entering into innovative arrangements that would improve quality outcomes, produce health system efficiencies, and lower costs (or slow their rate of growth),” wrote the Centers for Medicare & Medicaid Services in the Federal Register on Dec. 2, 2020.

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Effective Jan. 19, 2021, new rules to modernize the AKS and Stark Law became effective, as part of the federal government’s “Regulatory Sprint to Coordinated Care” program. The program is designed to encourage: ʯ A patient’s ability to understand treatment plans and make empowered decisions. ʯ Providers’ alignment on an end-to-end treatment approach (that is, coordination among providers along the patient’s full care journey).

ʯ Incentives for providers to coordinate, collaborate, and provide patients with tools to be more involved. ʯ Information-sharing among providers, facilities, and other stakeholders in a manner that facilitates efficient care while preserving and protecting patient access to data.

Repertoire asked Mollie Gelburd, associate director of government affairs for the Medical Group Management Association, to spell out how the new rules might affect providers’ actions, as well as suppliers’ role in coordinated-care.

Repertoire: Up until January 2021, how have the Stark Law and anti-kickback statute interfered with providers’ coordination-of-care arrangements?

Mollie Gelburd: Any type of shared incentive payments involved in care coordination arrangements, such as an accountable care organization, is suspect under Stark if they include Medicare payments. The potential for liability under the Stark Law is much broader than the AKS, as it is a strict liability law. Any Stark violation is subject to the same penalty, whether the nature of the infraction is innocuous or not.

Here’s an example: Several medical group practices are interested in forming a care coordination model for diabetes patients to improve clinical outcomes, promote efficient use of resources, and improve communication among providers involved in the patient’s care. A primary care provider coordinates care with a dietician, nurse educator, endocrinologist, and other specialists as needed across multiple sites of service, with the goal of reducing A1C levels and mitigating comorbidities. Participating providers receive a share of any resulting savings.

Under the Stark Law, there was no express protection for cost-saving programs, so practices would have been prohibited from entering into a care coordination plan with a shared savings component, opening themselves up to possible liability.

The AKS is a criminal law, but there’s an “intent” element that’s missing from Stark. Anyone who knowingly and willfully receives or pays anything of value (remuneration) as an incentive to influence the referral of federal health program business can be held accountable.

Therefore, any support provided by an entity, such as a hospital providing support to an entity with which it is coordinating care, such as a group practice, is remuneration under the AKS and therefore subject to scrutiny.

Repertoire: What types of “legitimate activities” to coordinate and improve care are now OK in the eyes of CMS, which were not OK prior to Jan. 19?

Gelburd: The types of payment arrangements used in value-based models are unlikely to fit within any of the Stark Law exceptions that existed prior to the final rule.

That would include a gainsharing arrangement where a hospital and physician practices agree to share in any financial savings for cost-efficient care, or pay back losses for care that exceeds a predetermined benchmark, such as in the example above. Most Stark exceptions prohibit compensation that varies with the volume or value of referrals, so a key problem with an arrangement like gainsharing is, it inevitably links physician payments to the volume or value of referrals. It’s possible that this type of arrangement could be structured to fit within one of the three new Stark exceptions … but a group practice would likely have to consult counsel or a compliance expert to ensure they are not running afoul of the requirements.

MGMA supports and appreciates the Stark Law value-based arrangement exception finalized by CMS, as it may create opportunities for more group practices to participate in care coordination arrangements to improve patient care.

Repertoire: The rule regarding the anti-kickback statute says that some entities are NOT eligible for value-based safe harbors, including medical device distributors and manufacturers of devices or medical supplies. What does that mean?

Gelburd: The Office of the Inspector General originally stated in the proposed rule that entities ineligible to use new value-based safe harbors are pharmaceutical manufacturers, distributors, and wholesalers; pharmacy benefit managers; laboratory companies; pharmacies that primarily compound drugs or primarily dispense compounded drugs; manufacturers of devices www.repertoiremag.com

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SHORTEN OR TIME1*

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*STRATAFIX™ Knotless Tissue Control Device shortened OR time compared to traditional sutures in total hip arthroplasty, based on retrospective analysis of 5958 cases from the Premier Perspective® Hospital Database. † Patients with DERMABOND PRINEO System had lower readmissions than patients with skin staples in a retrospective, observational study using the Premier Healthcare Database in total knee arthroplasty (N=1942), 2012-2015; LOS 2.8 days vs 3.2, P=0.002; discharge to SNF 26% vs 39%, P=0.011; 30-day readmissions 1.8 vs 4.4%, P=0.006. ‡ Plus Sutures were proven in vivo to kill bacteria on the suture known to be associated with SSIs (Staphylococcus aureus, Staphylococcus epidermidis, methicillin-resistant S aureus [MRSA], methicillin-resistant S epidermidis [MRSE], Escherichia coli, Klebsiella pneumoniae) in an animal model. § Compared to traditional sutures based on a retrospective analysis of 7,410 spinal fusion and laminectomy procedures from the Premier Perspective® Hospital Database, using STRATAFIX barbed sutures was associated with lower OR time (P=0.015) and costs (P=0.02) than traditional sutures. || In a meta-analysis of 21 RCTs, 6462 patients, 95% CI: (14, 40%), P<0.001. ¶ Ethicon Plus Antibacterial Sutures (MONOCRYL® Plus Antibacterial [poliglecaprone 25] Suture, Coated VICRYL® Plus Antibacterial [polyglactin 910] Suture, and PDS® Plus Antibacterial [polydioxanone] Suture).

ACS/SIS=American College of Surgeons/Surgical Infection Society; CDC=Centers for Disease Control and Prevention; LOS=length of stay; NICE=National Institute for Health and Care Excellence; RCT=randomized clinical trial; RKI=Robert Koch Institute; SNF=skilled nursing facility; SSI=surgical site infection; WHO=World Health Organization.

In today’s changing surgical environment, your customers need Ethicon Advanced Wound Closure products In addition to Ethicon’s renowned sutures and topical skin adhesive products, 3 advanced technologies can help your surgical customers successfully meet today’s challenges in their procedures.

STRATAFIX® Knotless Tissue Control Devices • Shorter OR times1* • Lower OR costs6§ • Antibacterial (sutures with Plus technology only)

DERMABOND® PRINEO® Skin Closure System • Shorter length of stay2† • Reduced readmissions2† • Simplified at-home wound care for patients7

Plus Antibacterial Sutures • Only triclosan-coated sutures available worldwide • 28% reduction in SSI risk with triclosan-coated sutures shown in meta-analysis8||¶ • Triclosan-coated sutures recommended by 6 health authorities including WHO and CDC9-13# #CDC, WHO, ACS/SIS, NICE, and RKI guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not speciic to any one brand.

For complete indications, contraindications, warnings, precautions, and adverse events, please reference full package insert.

References: 1. Sutton N, Schmitz ND, Johnston SS. Comparing outcomes between barbed and conventional sutures in patients undergoing knee or hip arthroplasty. J Comp Eff Res. 2018;7(10):975-987. doi:10.2217/cer-2018-0047. 2. Sutton N, Schmitz ND, Johnston SS. Economic and clinical comparison of 2-octyl cyanoacrylate/polymer mesh tape with skin staples in total knee replacement. J Wound Care. 2018;27(Sup4):S12-S22. 3. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficacy of PDS Plus (Polidioxanone with Triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451-457. 4. Storch ML, Rothenburger S, Jacinto G. Experimental Efficacy Study of Coated VICRYL Plus Antibacterial Suture in Guinea Pigs Challenged with Staphylococcus aureus. Surg Infect (Larchmt). 2004;5(3):281-288. 5. Ming X, Rothenburger S, Nichols MM, Rothenburger S. In vivo antibacterial efficacy of MONOCRYL Plus Antibacterial (Poliglecaprone 25 with Triclosan) suture. Surg Infect (Larchmt). 2007;8(2):1-5. 6. Johnston S, Chen B, Tommaselli G, Jain S, Pracyk J. Barbed and conventional sutures in spinal surgery patients: an economic and clinical outcomes comparison. J Wound Care. 2020;29(5):S9-S20. 7. De Cock E, van Nooten F, Mueller K, et al.

Changing the surgical wound closure management pathway: time and supplies with PRINEO* vs. standard of care for abdominoplasty surgery in Germany. Poster presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 11th Annual European Congress, November 8-11, 2008; Athens, Greece. 8. Ahmed I, Boulton AJ, Rizvi S, et al.

The use of triclosan-coated sutures to prevent surgical site infections: a systematic review and meta-analysis of the literature. BMJ Open. 2019;9:e029727. doi:10.1136/bmjopen-2019-029727.

9. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017;152(8):784-791.

10. WHO Global Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2016. https://www.who.int/gpsc/ssi-guidelines/en. Accessed October 6, 2020.

11. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2016;224(1):59-74.

12. NICE Guideline Updates Team (UK). Surgical site infection: prevention and treatment. NICE website. https://www.nice.org.uk/guidance/ng125/chapter/Recommendations#closuremethods.

Accessed April 3, 2020. 13. Prevention of postoperative wound infections. Recommendation of the Committee for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute. Bundesgesundheitsbl. 2018;61(4):448-473.

©2020 Ethicon US, LLC. All rights reserved. 155365-201009

TRENDS or medical supplies; entities or individuals that sell or rent durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) (other than a pharmacy or a physician, provider, or other entity that primarily furnishes services); and medical device distributors and wholesalers. However, in the final rule, the OIG created a pathway for “limited technology participants” to receive safe harbor protection in some instances. “Limited technology participants” include manufacturers of a device or medical supply or a DMEPOS company that is a value-based-enterprise (VBE) participant that exchange digital health technology with another VBE participant or a VBE. That said, they are restricted from conditioning the exchange of remuneration on any recipient’s exclusive use, or minimum purchase, of any item or service manufactured, distributed, or sold by those entities.

Repertoire: In your opinion, are further changes or revisions needed to the Stark Law and AKS? Gelburd: MGMA supports and appreciates the Stark Law value-based arrangement exception finalized by CMS, as it may create opportunities for more group practices to participate in care coordination arrangements to improve patient care. However, MGMA believes that rewording and tinkering with terminology does not resolve the fundamental complexity and

overall problems with the law. Moreover, changes to highly technical terms do not nullify the need for group practices to consult with attorneys, compliance experts, and/or valuation professionals when evaluating Stark Law compliance. This adds unnecessary expenses that would be better spent on investments that drive improvements in patient care.

In our opinion, here are some potential solutions: ʯ Repeal the compensation arrangement provision in Stark, leaving intact the restriction on self-referrals for physicians with an ownership or investment interest. Doing this would still leave abusive referral relationships involving compensation arrangements subject to the AKS in combination with the False Claims Act. ʯ “Inverse” the law, to permit all relationships, except if specifically identified as a prohibited relationship. This would remedy the current patchwork of exceptions approach. ʯ Simplify the definition of what it means to be a “group practice,” which currently entails seven technical requirements. ʯ Completely revise the penalty provisions in Stark, so as to limit fines to situations where the prohibited referrals result in some demonstrable harm to the government or the patients served.

Safety-net hospitals favor new rules America’s Essential Hospitals is a national trade association of more than 300 public and other nonprofit hospitals with a safety-net role. Maryellen Guinan, principal policy analyst, responded to Repertoire’s request for the association’s viewpoint on the new rules regarding Stark Law and the anti-kickback statute.

“We appreciate and support HHS’ work to prioritize care coordination, improve delivery across the care continuum, and reduce regulatory impediments to our hospitals’ fully engaging in value-based care and alternative payment models.

The final rules from OIG and CMS are welcome steps toward aligning fraud and abuse laws with the value-driven health care system of today – and, just as important, of tomorrow.

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“The new exceptions to the Stark Law and safe harbors under the anti-kickback statute vary based on the level of financial risk assumed by the parties involved in the valuebased arrangement. Greater protection is provided for those who have assumed full or substantial financial risk, compared with those in upside-only arrangements.

“What these exceptions and safe harbors lack is an acknowledgment that necessary upfront and ongoing investments constitute a downside risk – for example, investments in proactive data management, technology upgrades, and redesign processes. We believe investments in infrastructure and care redesign, as well as clinical risk essential hospitals assume in treating complex patients, should be considered a form of downside risk. We encourage further work by OIG and CMS in this area.”

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HEALTHY REPS

Health news and notes Connecting with someone with Alzheimer’s Mayo Clinic says that even if your loved one with Alzheimer’s doesn’t recognize you or can’t communicate verbally, you can still show reassurance and love. To maintain a connection, use your loved one’s senses: ʯ Touch. Hold their hand. Brush his or her hair.

Gently massage their hands, legs or feet. ʯ Smell. The scent of a favorite perfume, flower or food might be comforting. ʯ Sight. Show your loved one a video with scenes of nature and soft, calming sounds. Or take them to look at a garden or watch the birds. ʯ Hearing. Read aloud, even if your loved one can’t understand the words. The tone and rhythm of your voice might be soothing.

appeared to trigger an immune reaction that included T cells from the blood and the brain’s scavenging microglia. The dark spots showed a different pattern, with leaky vessels and clots but no evidence of an immune reaction.

Researchers continue to explore how COVID-19 affects the brain and triggers neurological symptoms.

Ill effects of light drinking Despite the purported cardiovascular benefits of light drinking, small amounts of alcohol were linked with incident atrial fibrillation (Afib) in a large observational study, reports MedPage Today. Increased Afib risk was observed with just one daily drink containing 12 g ethanol, whether the beverage was 120 mL of wine (four-fifths of one standard glass), 330 mL of beer (nearly a can’s worth), or 40 mL of spirits (roughly one shot), reported Renate Schnabel, M.D., of University Heart & Vascular Center Hamburg, Germany, and colleagues.

Even very low alcohol consumption, at 2 g per day, was marginally associated with Afib risk over nearly 14 years of follow-up, they wrote in the European Heart Journal. Findings were consistent for men and women.

Promising news on cancer front

COVID-19’s effects on the brain Suggestions that SARS-CoV-2 might cross the blood-brain barrier and invade the brain were ruled out in a study conducted by the National Institutes of Health. Using a highpowered magnetic resonance imaging scanner to examine postmortem tissue from 19 patients, researchers found an unusual number of bright spots, a sign of inflammation.

They also showed dark spots, which indicate bleeding. A closer look at the bright spots showed that tiny blood vessels in those areas were thinner than normal and, in some cases, leaked blood proteins into the brain. This leakage 40

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Researchers in January reported another record one-year decline in the U.S. cancer death rate, a drop they attribute to success against lung cancer. The overall cancer death rate has been falling since 1991. From 2017 to 2018, it fell 2.4%, according to an American Cancer Society report, topping the record 2.2% drop reported the year before. Lung cancer accounted for almost half of the overall decline in cancer deaths in the past five years, the society reported. Most lung cancer cases are tied to smoking, and decades of declining smoking rates have led to falling rates of lung cancer illnesses and deaths. But experts say the drop in deaths has been accelerated by refinements in surgery, better diagnostic scanning, more precise use of radiation and the impact of newer drugs.

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QUICK BYTES Editor’s note: Technology is playing an increasing role in the day-to-day business of sales reps. In this department, Repertoire will profile the latest developments in software and gadgets that reps can use for work and play.

Technology news YouTube expanding its reach to patients YouTube is unveiling a program to address the digital health needs of consumers and the desire for clinicians to communicate with them. With more than 2 billion signed-in monthly users, YouTube believes it offers a unique opportunity for clinicians to expand their reach.

The company is working with several healthcare organizations, including the American Public Health Association, Cleveland Clinic, The Forum at the Harvard School of Public Health, Mayo Clinic, Osmosis, Psych Hub, and the National Academy of Medicine, to create high quality health content for viewers around the world.

Not bad for $200 Over the past several years, OnePlus has grown from a niche brand to a powerhouse in the U.S. market, according to PC Magazine. Its strategy is simple: Affordable prices. The OnePlus Nord N10 5G and OnePlus Nord N100 were scheduled to be available at T-Mobile, Metro

by T-Mobile in late January. With a 6.49-inch display and 90Hz refresh rate, the $300 Nord N10 5G is powered by a Qualcomm Snapdragon 690 chipset, and sports 6GB of RAM and 128GB of storage. If you’re

not worried about 5G or simply want to save money, the OnePlus Nord N100 is a pared-down version of Nord N10 5G, and costs under $200. It features a 6.52inch display, stereo speakers, and a 5,000mAh battery with 18W fast charging.

Straitlaced business laptops Many Americans changed the way they work in 2020, leaving the office and working primarily from home.

The idea of having a work computer at the office and a personal computer at home also went out the window, according to CNET. But because of the long development cycle of new laptops, desktops and tablets, no PC maker could realistically take these shifts and engineer them into new products in time for CES 2021, the big consumer technology show. So they have shifted the narrative and emphasized new or updated products that are more appropriate for the current reality. Instead of firstgeneration folding screens and colorful gaming rigs, much of the attention in 2021 will be on laptops with better webcams, better microphones, better security features – basically, the things your company IT department looks for in a new work laptop.

Not so long ago …

Speaking of CES, the consumer technology show, organizers compiled a timeline of landmark technologies from shows between 1970 and 2015:

ʯ 1970: Videocassette recorder (VCR) ʯ 1974: Laserdisc player ʯ 1981: Camcorder and compact disc player

ʯ 1990: Digital audio technology ʯ 1991: Compact disc – interactive ʯ 1994: Digital satellite system (DSS) ʯ 1996: Digital versatile disk (DVD) ʯ 1998: High definition television (HDTV)

ʯ 1999: Hard-disc VCR (PVR) ʯ 2000: Satellite radio

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ʯ 2001: Microsoft Xbox and

plasma TV ʯ 2002: Home media server ʯ 2003: Blu-Ray DVD and HDTV PVR ʯ 2004: HD radio ʯ 2005: IP TV ʯ 2007: Convergence of content and technology ʯ 2008: OLED TV ʯ 2009: 3D HDTV ʯ 2010: Tablets, netbooks and Android devices

ʯ 2011: Connected TV, smart appli-

ances, Android Honeycomb, Ford’s Electric Focus, Motorola Atrix, Microsoft Avatar Kinect, 2011 ʯ 2012: Ultrabooks, 3D OLED, Android 4.0 tablets ʯ 2013: Ultra HDTV, Flexible OLED, driverless car technology, ʯ 2014: 3D printers, sensor technology, curved UHD, wearable technologies ʯ 2015: 4K UHD, virtual reality, unmanned systems

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A Thoughtful Approach to Pandemic Response Efforts

By the time you read this column, the Biden Administration will have a couple of months in

By Linda Rouse O’Neill

the White House under its belt. During this time, HIDA has been conducting meaningful outreach and building relationships within the new Administration.

There has been a flurry of Executive Orders from the Oval Office, including one invoking the Defense Production Act (DPA) as a means to fight COVID-19. The message we’re taking to our federal partners is that the DPA could be a useful tool provided that it is focused on increasing the availability of much-needed medical supplies while allowing the supply chain that is working to continue doing its job.

Here are some of the recommendations that HIDA has made: ʯ It’s important that the federal government partner with the existing healthcare supply chain and its experts to share data, crack down on fraudulent product and opportunistic brokers, and remove barriers that are slowing delivery. ʯ The federal government should take a thoughtful approach to stockpiling and other purchases that ensures needed supplies get to the front lines and not stuck on the back shelves. This should include collaborating with distributors on how and when to stockpile. Medical supply distributors have the expertise needed to help manage large inventories that could be at risk of expiration, damage, or obsolescence. ʯ The COVID-19 pandemic created an unprecedented global demand for medical supplies, which existing manufacturing capacity could not meet.

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ʯ Throughout the pandemic, medical products distributors have collaborated with the federal government as trusted partners.

Every day, distributors are using their existing infrastructure to reliably deliver essential medical supplies the last mile to get them into the hands of providers. ʯ During the first three quarters of 2020, medical products distributors moved more than 90 billion units of pandemic-related supplies – including more than 39 billion units of PPE. That’s a 15% increase over the pandemic supplies delivered by distributors during the same timeframe in 2019 and a 20% increase in the units of PPE delivered in that period. ʯ Distributors stand ready, willing, and able to deliver critical supplies to healthcare providers and their patients.

REP CORNER

No Doubt About it Some people fall into supply chain management by accident. Katie Vincent jumped into it.

As a student at Iowa State University in Ames, Katie Vincent thought she would pursue a career in marketing,

perhaps advertising or brand management. But she felt something was missing. She considered switching majors to engineering but then took a required introductory course in supply chain. “The interconnectedness of marketing, manufacturing, logistics, transportation, etc., just fascinated me, and I decided that supply chain and logistics was a happy medium between marketing and engineering.” Today she is senior account manager for Owens & Minor in the Des Moines metropolitan area.

Katie Vincent

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She grew up in New London, Iowa, a city of about 2,500 in the southeastern corner of the state.

Her father, Paul Lorber, has owned an independent insurance agency for over 30 years. Her mother, Ana Lair, has been the Henry County Treasurer for 17 years and was president of the Iowa State Treasurers Association in 2013-2014.

“My mom started a new career later in life when she decided to run for county treasurer. She had worked in the treasurer’s office years before and then stayed home with me until I went to school. She then made the decision to run for county treasurer and has run unopposed for five election cycles. She really loves what she does.

“Growing up, I was used to Dad getting calls at home at night from his insureds if they had been in a car accident or had a house fire,” she continues. “Obviously, there wasn’t a lot he could do at that moment, but they felt better just being reassured that they were insured and things would be OK.” While she was in high school, she worked for her dad in the summers. “He would let me write memos and letters to customers and would edit them for me before we sent them. He taught me a lot about customer service and how to build customer relationships.”

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REP CORNER A logistics career After graduating from Iowa State, she took a number of exceedingly senior logistics roles. Her first stop was JCPenney, as a supervisor, managing merchandise flow from ports of entry to the company’s retail stores. As a recent college grad managing 50 to 100 people, almost all older than she, “I learned a lot about balancing holding people accountable and motivating them at the same time.”

Next she served as logistics manager for Pamida, a chain of department stores with approximately 200 locations in the rural Midwest and West Central U.S. “I had the best boss I’ve ever had there,” she says.

“She was fantastic about pushing me and giving me feedback, while at the same time being incredibly supportive and teaching me.”

as operations manager for logistics. In that last role, she worked with Werner’s 3PL customers on such things as order management, FTL (full truckload), project management, intermodal, expedited, air freight, ocean freight and LTL (less than truckload).

“I went from customer to service provider,” she says. “That was an interesting transition. I was more empathetic to both sides after this experience.”

In 2014, she joined Amazon in Indianapolis, Indiana, first as an area manager, then as operations manager.

“Amazon is truly customer-obsessed,” she says. “It drives everything they do, and that still drives me in my current role. It always amazed me that as big as Amazon was, they were able to adapt and change extremely fast. To me, that was the coolest part about working there.”

‘ I can’t help this feeling that this is where I’m supposed to be.’

At Pamida, Vincent gained more valuable experience in logistics. She managed daily inbound transportation operations; oversaw inbound import freight; collaborated with transportation providers, freight forwarders, and third-party warehouses; conducted analyses to identify choke points and cost-savings opportunities in Pamida’s supply chain; and developed contingency plans to mitigate supply chain risk.

She took a tour of the port in Long Beach, California. “It’s hard to understand the scale of what happens there unless you’ve seen it.”

In 2012, she joined Werner Enterprises, the transportation and logistics firm, first as a project analyst, then export operations manager, and then 48

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After four years at Amazon, she was ready for a change. “I had been in supply chain operations for about nine years at that point. I wanted to use the skills I’d picked up over the years in an industry where I could make a difference. Healthcare seemed like a good place to start.”

She interviewed for a supply chain position in a healthcare system.

She didn’t get the job, but she got a call several months later from Owens & Minor about a position there. “I thought Owens & Minor would be a great fit for me. It was distribution, it was customer service, it was sales, it was process improvement.” She joined the company in October 2018. “I can’t help this feeling that this is where I’m supposed to be,” she says today.

A new dimension Healthcare has added a new dimension to her logistics experience. “These are not just widgets you’re moving, as in retail distribution. You’re working to improve efficiency, but never at the cost of patient outcomes. My friends and family live in the communities where my hospitals are,” she adds, “so I always try to keep that in mind. It really drives what I do.”

She brings insights from retail and commercial logistics with her.

“New technology can have a huge impact on improving supply chain visibility, right-sizing inventories, and improving cash flow. These are things that would benefit a health system just as much as a retailer.”

At Owens & Minor, she considers her role to be more partnering than selling. She works with customers on standardization, sourcing, product visibility and more. After spending time on the other side of the desk, she learned that successful salespeople focus on what the customer wants to talk about, not about what the salesperson is selling.

While in the retail industry, she participated in the Retail Industry Leaders Association’s Women in Supply Chain Network, an initiative to encourage executives to increase the number of women in the retail supply chain. “I think it’s so important to continue to encourage women to get into supply chain. Supply chain needs a wide variety of perspectives to continue to change and improve. I have met some powerhouse women in my career, and it’s crazy to think what would have happened if they hadn’t gotten into the field they did.”

Katie Vincent lives with her seven-year-old Vizsla, a dog named Rosie, in downtown Des Moines, a city she loves and describes as “a Midwestern hidden treasure.”

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THANK YOU 2021

PWH® LEADERSHIP SUMMIT SPONSORS:

MONDAY, MAY 17 2:30 – 3:30 pm ET 4:00 – 5:00 pm ET

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PWH® Showcase Opening Keynote: The Power of Profitable Conversations – Leadership, AmyK Hutchens Chats & Cheers: Virtual Networking

TUESDAY, MAY 18 9:00 am ET 10:00 am ET

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Leadership Panel: Looking Back, Moving Forward Closing Keynote: Connecting to Life through F.U.N., Paul Long

All times listed are Eastern time. Schedule subject to change.

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NEWS

Industry News Vizient invests with PPE manufacturers to expand, stabilize U.S.-based supply Vizient, Inc. (Irving, TX) has entered into strategic partnership agreements with Encompass, Standard Textile, and Prestige Ameritech in order to expand the available supply of a variety of needed personal protective equipment (PPE) items.

Building on an earlier agreement with Encompass Group, LLC for 19 million disposable gowns, in August, Vizient announced a new agreement with the company to provide an additional 65 million AAMI level 3 disposable isolation gowns manufactured annually in North America to its member hospitals.

Since then, Vizient has partnered to help Encompass start a new, automated manufacturing line for disposable gowns in the U.S., bringing both supply and onshore resiliency for these products, the company says.

The new manufacturing line is expected to be up and running in the first quarter of 2022.

Vizient has also partnered with Standard Textile to expand its US-based manufacturing operations for Vizient members. In the initial months of the pandemic, the agreement provided 1.4 million reusable fabric cover gowns (approximately 75 uses each), 1 million reusable fabric face masks and 500,000 reusable plastic face shields for Vizient members.

In August, Standard Textile joined the Novaplus Enhanced Supply Program, which provides Vizient members with globally diversified manufacturing and USbased stockpiles.

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As a result, an additional 5.2 million reusable gowns, 1.3 million shoe covers, 1.5 million bouffant caps, 1.5 million skull caps and 1.3 million fabric face masks per year will be available for Vizient members who participate in the program.

Vizient also has a commitment to Prestige Ameritech for 9 million, U.S.-made N95 masks over a 12-month period. Since the agreement launched in April 2020, approximately 700,000 masks have been delivered monthly to program participants, Vizient said.

Sysmex, Roche renew agreement for global alliance Roche (Basel, Switzerland) announced that, on December 14, 2020, it signed a Global Business Partnership Agreement (GBPA) with Sysmex.

Sysmex and Roche initially signed a GBPA on December 14, 2020 to form a framework for their alliance and commenced activities accordingly on January 1, 2021. The GBPA includes the DSSA and the TLSA, as well as an IT Solutions Collaboration Agreement, and the two companies have agreed to develop a next-generation global alliance.

Roche will continue to distribute and support Sysmex hematology products in selected countries in Central and South America, Europe, southern Africa, and Oceania. Sysmex plans to boost direct sales and support structures in Spain and India, both of which were added to their list of territories pursuant to the TLSA, in a bid to increase the resilience of the two companies’ global sales and service network.

EDUCATIONAL F O U N DAT I O N

EXECUTIVE CONFERENCE

Supply, Demand & Change

The Next Normal For The Healthcare Supply Chain

March 29–31, 2021 | 100% Virtual Event | Register At HIDA.org

Education Sessions

Roy Schoenberg

Alan Beaulieu

Robert Michel

Nahid Bhadelia, MD

Amwell

Economist

DARK Daily and the Dark Report

Boston Medical Center

Explore which telemedicine trends spurred by COVID-19 are here to stay, and how your company should respond.

Get business-focused economic advice from HIDA members’ favorite economist, Alan Beaulieu.

Examine how the pandemic moved diagnostics to front-and-center, and how this segment can leverage increased visibility moving forward.

Discuss the worldwide preparedness learnings from COVID, and whether we are ready for the next pandemic.

Participate From Your Home Or Office Live, Interactive Sessions | Real-Time Networking And Meetings Convenience And Cost Savings | Safety STRATEGIC EDUCATION & NETWORKING FOR EXECUTIVES

NEWS

This GBPA also introduced an IT Solutions Collaboration Agreement. In the newly defined collaboration, the two companies have agreed to utilize their respective IT platforms to improve customer experience in the short to mid-term, with a longer term ambition to use the IT systems to lead to improved clinical decision making.

The GBP agreement will run until the end of 2030.

BD announces data showing its antigen test may be more selective in detecting infectious COVID-19 patients than molecular tests BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced the publication of a peer-reviewed study that it says shows BD’s antigen test may be more selective than PCR (polymerase chain reaction) molecular tests at detecting people who are contagious and able to spread COVID-19 disease.

The study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth in the cell culture test indicates the presence of live virus in the patient sample, which may indicate the presence of infectious virus at the time the sample was taken. If no growth is present in the viral cell culture test, it is likely that there wasn’t enough viable virus for the patient to be contagious at the time the sample was taken.

Out of 38 positive PCR result specimens tested, only 28 were positive using the cell culture technique.

The antigen tests, conducted using the BD Veritor Plus System, were positive in 27 of the 28 cell culture positive tests. The company says that this data suggests that 10 of the 38 PCR positive results were potentially identifying non-infectious individuals, meaning PCR detected viral RNA fragments or small amounts of intact SARS-CoV-2 virus and that the patient wasn’t actually contagious at the time the sample was taken.

However, the BD antigen test agreed with all but one cell culture positive test.

“Point-of-care antigen tests, as demonstrated in this study with the BD Veritor Plus System, have the potential to significantly change the public health interventions needed to minimize the spread of COVID-19,” said Dr. Charles Cooper, study co-author and VP of Medical Affairs for BD. “By providing a more relevant test to identify individuals that are likely to be shedding infectious virus and therefore transmit SARS-CoV-2, we will be in a better position to contain its spread. Plus, the 52

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low cost and scalability of antigen-based testing makes it an important tool to contain and suppress COVID-19 community transmission.”

Medical drone startup to begin COVID vaccine delivery Zipline Inc. (San Francisco, CA), a drone delivery service that specializes in medical supplies, announced that it plans to begin transporting COVID-19 vaccines in April.

The startup said in a release that it is partnering with “a leading manufacturer of COVID-19 vaccines” in all of the markets where its drones currently operate.

Zipline has been delivering medicine and supplies to rural clinics in Rwanda and Ghana since 2016 and, last year, began delivering personal protective equipment to hospitals and clinics in North Carolina. It plans to add operations in Nigeria later this year.

Zipline declined to specify its vaccine partner but said it has built a system that can deliver ultra-low temperature medical supplies, including “all leading COVID-19 vaccines,” according to Bloomberg News.

The vaccine developed by Pfizer Inc and BioNTech SE must be stored in extreme cold at temperatures of negative 70 degrees Celsius, requiring special freezers.

Zipline plans to add these ultra cold refrigerators at all of its distribution centers.

Pfizer, responding to an earlier request for comment about whether it is working with Zipline, said in a statement, “Pfizer supports Zipline’s efforts to expand access to vaccines and medicines to those in hard to reach geographies.”

Vaccine distribution sites without ultra-low refrigeration have limited options: They can forego Pfizer’s vaccine entirely opting for the Moderna Inc. alternative and hoping for additional vaccines from Johnson & Johnson and others to gain FDA approval; keep Pfizer’s vaccine vials on dry ice for up to 30 days; or keep them in standard refrigerators for up to five days. Zipline can help bypass the need for freezers – and prevent vaccines from spoiling – by repeatedly supplying a small numbers of doses on demand.

A clinic in its network, the company says, will be able to request a few dozen doses of a COVID-19 vaccine and receive them at an ultra low temperature in less than an hour.

Zipline’s fixed-wing, battery-powered drones navigate by GPS. They drop payloads of a few pounds each by parachute and can fly up to 100 miles round trip.

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