40 minute read
TRENDS
from REP Dec 20
Healthy People 2030
20 targets for your physician customers to meet
Every 10 years, the U.S. Department of Health and Human Services publishes
a 10-year plan for addressing the most critical public health priorities and challenges. Released in August 2020, Healthy People 2030 lists 355 measurable objectives with 10-year targets. Here are 20 that are worth sharing with your physician customers.
1 Objective
Increase the proportion of adults who receive appropriate evidence-based clinical preventive services
Rationale
Access to preventive health care can prevent both disease and early death.
Baseline
8% of adults aged 35 years and over received all of the recommended high-priority-appropriate clinical preventive services in 2015
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Increase the proportion of persons with a usual primary care provider Having a primary care provider is important for maintaining health and preventing and managing serious diseases. 76% of persons had a usual primary care provider in 2017
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Increase the proportion of adults who receive a lung cancer screening based on the most recent guidelines Lung cancer screening can help prevent deaths in people at high risk – mostly current and former smokers. But screening rates in this population remain low. 4.5% of adults aged 55 to 80 years received a lung cancer screening based on the most recent guidelines in 2015
Increase the proportion of females who receive a breast cancer screening based on the most recent guidelines Without screening, breast cancer may be diagnosed at a later stage and lead to death. 72.8% of females aged 50 to 74 years received a breast cancer screening in 2018
Increase the proportion of adults who receive a colorectal cancer screening based on the most recent guidelines Colorectal cancer is one of the most common causes of cancer deaths in the United States, particularly in minority populations
Reduce the proportion of adults with undiagnosed prediabetes Millions of people in the United States have prediabetes, but many don’t know it. People with prediabetes are at higher risk for type 2 diabetes, heart disease and stroke. 65.2% of adults aged 50 to 75 years received a colorectal cancer screening based on the most recent guidelines in 2018
38% of adults aged 18 years and over, who had not been diagnosed with prediabetes or diabetes, had undiagnosed prediabetes in 2013-16
Reduce the proportion of adults with diagnosed diabetes with an A1c value greater than 9.0 percent A1c levels above 9% increase the risk of complications. 18.7% of adults aged 18 years and over with diagnosed diabetes had an A1c value greater than 9% in 2013-16
Increase the proportion of adults with diagnosed diabetes who receive an annual urinary albumin test Screening for high levels of albumin in the urine is to help prevent end-stage kidney disease in people with diabetes. 48.7% of Medicare beneficiaries with diabetes mellitus had urinary albumin testing in 2016
Reduce blood lead levels in children aged 1 to 5 years Lead can damage children’s kidneys, blood, and brains – and at high levels can cause coma, seizures and death. 3.31 micrograms per deciliter (µg/dL) was the concentration level of lead in blood samples at which 97.5% of the population aged 1 to 5 years was at or below in 2013-16
Reduce hospital-onset Clostridioides difficile infections (CDI) The number of people who get C. diff has been higher than ever in recent years, and it causes thousands of deaths in the United States each year. 1.00 was the national Standardized Infection Ratio (SIR) for hospital-onset CDI in 2015
Target
10.9%
84%
7.5%
77.1%
74.4%
33.2%
11.6%
66.6%
1.18 µg/dL
0.70 SIR
11 Objective
Reduce hospital-onset methicillin-resistant Staphylococcus aureus (MRSA) infections
12
Reduce the proportion of adults with hypertension
Rationale
MRSA is one of the most common causes of infections that people get in hospitals.
Baseline
1.00 was the national Standardized Infection Ratio (SIR) for hospital-onset MRSA bacteremia infections in 2015
People with high blood pressure are more likely to have coronary heart disease, stroke, heart failure and kidney disease. 29.5% of adults aged 18 years and over had hypertension in 2013-16
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Reduce the mean total blood cholesterol level among adults People with high blood cholesterol are more likely to have heart disease. 190.9 milligrams per deciliter (mg/dL) was the mean total blood cholesterol level for adults aged 20 years and over in 2013-16
Increase the proportion of persons aware they have chronic hepatitis B Untreated chronic hepatitis B can cause liver disease, cirrhosis, liver cancer and death. 32.4% of persons with chronic hepatitis B were aware they had chronic hepatitis B in 2013-16
Increase the proportion of persons aware they have chronic hepatitis C Untreated, chronic hepatitis C can cause liver disease, cirrhosis, liver cancer, and death.
Reduce the rate of hospital admissions for urinary tract infections (UDIs) among older adults UDIs are the second most common type of infection in older adults. When not treated early, UTIs can lead to kidney failure and death. 55.6% of persons with chronic hepatitis C were aware they had chronic hepatitis C in 2013-16
551.3 hospital admissions for UDIs per 100,000 adults aged 65 years and over occurred in 2016
Reduce the rate of emergencydepartment visits due to falls among older adults
Reduce the proportion of adults aged 45 years and over with moderate and severe periodontitis Falls are the leading cause of injury in older adults, often due to balance problems, poor vision, or dementia – or if they take several medications. 6,052.2 emergency department (ED) visits for falls per 100,000 adults aged 65 years and over occurred in 2016
Controlling diabetes and helping people quit smoking can help prevent gum disease, which can lead to tooth loss. 44.5% of adults aged 45 years and over had moderate and severe periodontitis in 2015-16
Target
0.50 SIR
27.7%
186.4 mg/dL
56%
74.2%
496.2 per 100,000 hospital admissions
5,447 ED visits per 100,000 adults
39.3%
19
Reduce deaths from chronic obstructive pulmonary disease (COPD) among adults COPD is a group of diseases – including emphysema, chronic bronchitis, and non-reversible asthma – that make it hard to breathe and can cause death. 110 COPD deaths per 100,000 adults aged 45 years and over occurred in 2018
107.2 COPD deaths per 100,000 adults
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Increase the proportion of adults with symptoms of obstructive sleep apnea who seek medical evaluation Many people in the United States have obstructive sleep apnea, which increases the risk of heart, brain and metabolic problems. 33.1% of adults aged 20 years and over with symptoms of obstructive sleep apnea sought medical evaluation in 2015-16 37.1%
Source: Healthy People 2030, Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services
It’s Simple
Retinal exams are more accessible than ever to primary care practices
Beginning Jan. 1, your primary care customers have a green light from Medicare to conduct retinal exams in their office. In doing so, they can improve patient-satisfaction and quality-of-care (HEDIS) indicators, bolster practice revenues, and most important, help their patients avoid a serious eye-related condition – diabetic retinopathy. And Repertoire readers can help by offering Hillrom’s new handheld retinal camera – the Welch Allyn® RetinaVue® 700 Imager and RetinaVue® care delivery model.
Most commercial health plans (and Medicare Advantage plans) have covered teleretinal exams in primary care settings for years, explains Thomas Grant, Director of Marketing, Vision Screening and Diagnostics at Hillrom. “The gap has been Medicare fee-for-service.” No longer.
The American Medical Association (AMA) has updated CPT® Code descriptions for retinal imaging codes 92227 and 92228 to specify retinal exams performed in primary care settings with remote interpretation. This is important, because Medicare fee-for-service covers about 30% of the patient population.
It’s also important because of the fact that an estimated 80% of patients living with diabetes will eventually develop diabetic retinopathy.
What is diabetic retinopathy?
The retina detects light and converts it to signals sent through the optic nerve to the brain. Chronically high blood sugar from diabetes is associated with damage to the tiny blood vessels in the retina. Those blood vessels can leak fluid or hemorrhage, distorting vision. In its most advanced stage, new abnormal blood vessels proliferate on the surface of the retina, which can lead to scarring and cell loss in the retina. Severe visual impairment and blindness can result.
Diabetic retinopathy often starts with no symptoms, leading individuals with diabetes to fail to attend routine appointments with an eye care provider. (It is estimated that 50% or less of patients with diabetes comply with annual retinal exams.) Unfortunately, once vision loss occurs, it is often too late to reverse its progression. However, 95% of vision loss due to diabetic retinopathy can be prevented with early detection and treatment.
Teleretinal imaging
Teleretinal imaging programs allow primary care providers to capture an image of the patient’s retina during a routine appointment using a specialized camera. The retinal images are uploaded and transmitted to a remote eye specialist, who provides a diagnosis to the initiating facility. Patients with signs of diabetic retinopathy are referred for further care with an ophthalmologist.
Care Delivery Model
Hillrom’s RetinaVue® Care Delivery Model comprises three components: ʯ Welch Allyn® RetinaVue® 700 Imager ʯ Welch Allyn® RetinaVue® Network Software ʯ Interpretation by board-certified ophthalmologists and retina specialists through RetinaVue,® P.C.
What you should know about CPT® Code updates
Recent updates to CPT® Code descriptions for diabetic retinal imaging are designed to more accurately indicate where the exam is performed and how the exam is interpreted. These changes ensure CMS coverage for diabetic retinal exams in primary care settings. ʯ AMA has updated CPT® Code descriptions for retinal imaging codes 92227 and 92228 to specify retinal exams performed in primary care settings with remote interpretation.
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The description for CPT® Code 92250 remains unchanged, but the AMA has clarified that this code is intended for exams performed in the same place where the interpretation is performed (e.g., in an ophthalmologist’s office).
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The appropriate CPT® Code for teleretinal programs with physician overread will be 92228 beginning January 1, 2021 with CMS coverage currently proposed at $28.71 per exam (final rates will be published in December) – an improvement over no national coverage policy.
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Although there is always downward pressure on reimbursement rates, expect commercial coverage rates to remain somewhat stable (approx. $70 on average) for the diabetic retinal exam in primary care settings – ensuring primary care providers are incentivized to continue efforts to close the HEDIS quality gap.
A simple and affordable handheld camera designed for primary care, RetinaVue® 700 Imager captures images automatically with image quality similar to more-expensive tabletop cameras used by eye specialists. The camera offers an automated retina imaging experience, featuring auto-alignment, autofocus and auto-capture, so minimal technique is required by the user. In fact, a study involving 35 registered nurses, licensed practical nurses and medical assistants showed that after a 30-minute practice session, all participants were able to capture a high-quality retinal image of each eye within three attempts.
In addition, the RetinaVue® 700 Imager can capture clear images through pupils as small as 2.5 mm, dramatically decreasing the need for dilating drops. And image capture can be completed in minutes, with minimal disruption to busy clinic workflow. of encrypted retinal images and management of exam data via HIPAA-compliant, SOC 2 Type II certified, FDAcleared software. Providers can meet their workflow and administrative needs, including population health management and quality reporting tools, to more effectively
RetinaVue® Network Software offers secure transfer of encrypted retinal images and management of exam data via HIPAA-compliant, SOC 2 Type II certified, FDA-cleared software.
manage retinal exam data. To streamline documentation, fully integrated, bi-directional interfaces with EMRs, including Allscripts, athenahealth, Cerner, Epic, NextGen and many others, are offered. Physicians may place retinal exam orders and automatically access diagnostic reports from the EMR.
Through RetinaVue,® P.C., board-certified, state-licensed ophthalmologists and retina specialists interpret retinal images and prepare
a comprehensive diagnostic report and referral/care plan generally in one business day, complete with ICD codes, signature, and license number. It is the first tele-ophthalmology provider to earn The Joint Commission’s Gold Seal of Approval® by demonstrating continuous compliance with
RetinaVue® Network Software offers secure transfer its Ambulatory Care Accreditation Standards.
Learn more
The convenience and quality of the RetinaVue® Care
Delivery Model, plus the coverage changes from Medicare, make access to recommended annual diabetic eye exams convenient for patients and primary care practices alike. Find out more by talking to your local Hillrom representative or visit www.RetinaVue.com.
CPT® Codes for retinal imaging
Current CPT Code Descriptions (CMS Rate) Code Changes and New Codes (CMS Rate*)
92250: Fundus photography with interpretation and report (CMS $45.83) 92250: Covers screening/diagnosis or monitoring where the review is performed by a physician in the office where the image was captured (CMS $36.78*)
92227: Screening examination for the asymptomatic patient at risk for a condition such as diabetic retinopathy (CMS $13.71) 92227: Imaging of retina for detection or monitoring of disease; with remote clinical staff review and report, unilateral or bilateral (CMS $15.49*)
92228: Remote imaging requirement for monitoring and management of patients with active retinal disease (CMS $34.65) 92228: Imaging of retina for detection or monitoring of disease; with remote physician or qualified health professional review and report, unilateral or bilateral (CMS $28.71*)
92229 (new): Imaging of retina for detection or monitoring of disease; with point-of-care automated analysis with diagnostic report; unilateral or bilateral (CMS $11.94*)
SIMPLE AND AFFORDABLE
It’s more accessible than ever to provide teleretinal exams to patients living with diabetes during a routine primary care visit. Most commercial healthcare plans provide coverage for diabetic retinal exams in primary care settings1 and Medicare will cover with CPT® Code 92228 beginning January 1, 2021.2
Visit retinavue.com to learn about the Welch Allyn® RetinaVue® care delivery model, a patient-centered solution to help eradicate diabetic retinopathy as the leading cause of blindness in American adults.3
* Based on a technical comparison against key market competitors (06-2020). 1 Commercial Coverage Policy data on file. Welch Allyn; 2019. 2 Medicare Program; CY 2021 Payment Policies under the Physician Fee Schedule
Proposed Rule [CMS-1734-P], 08/17/2020, https://s3.amazonaws.com/public-inspection. federalregister.gov/2020-17127.pdf 3 Centers for Disease Control and Prevention. Vision Health Initiative (VHI). https://www. cdc.gov/visionhealth/basics/ced/ Published September 29, 2015. UpdatedSeptember 29, 2015. Accessed January 30, 2020. © 2020 Welch Allyn, Inc. ALL RIGHTS RESERVED. APR149201 Rev 1 02-NOV-2020 ENG-US
The Welch Allyn® RetinaVue® 700 Imager— the world's most advanced handheld retinal camera.*
Year-End Reality Check
Any insights gained after a tough year?
In January, Repertoire published
predictions from several industry people about the year ahead. When we checked back with them this fall, they reported that despite its many challenges, the year 2020 offered sales reps new insights into how they can approach their job better than ever. Do you agree?
Ashley Brust, Vice president of corporate sales, West Coast, physician office
Medline Industries
Comment/Observation
Our ability to show up for our customers every single day via computer screen has given us a chance to connect with everyone from the nursing staff delivering care, to the supply chain directors who will do anything they can to provide PPE, to their teams, and to the executive-level managers who work tirelessly to plan for the future.
Agreed?
This has been the time to learn about the industry and keep up with all of the challenges our customers face in order to provide the support they need as they care for patients.
The COVID experience has brought to light how important it is to be a consultant for our customers. Successful sales reps have learned a lot about lab testing and inventory planning, which ultimately has helped them support their customers in a deeper way.
A good sales rep realizes it’s not just about shipping an item to a customer, but it’s about understanding the customer’s structure, goals, patient population and pain points. Understanding the ‘why’ behind a question can completely transform your response.
Our ability to see our customers [virtually] and have them ‘step into our homes’ has knocked down barriers, and I feel closer to many of my customers because of it.
Elizabeth Hilla, Senior vice president
HIDA
Comment/Observation
During the pandemic, distributor sales reps have had to focus on the absolute core of distribution – getting customers the products they need. They have coordinated with their sourcing teams as those teams vetted offers from thousands of suppliers to make sure customers received quality, FDA-approved products. They have helped customers and vendors manage allocations. And they’ve worked to make sure products got to the “hot spots” where they were needed most.
The pandemic has taught all of us involved in sales to be more empathic than ever. In good times, we might occasionally rush the pleasantries and jump into our sales pitch. During the pandemic, we instinctively knew not to do that. We asked our customer or prospect how they were doing, and we really listened to their answers. We likely spent much more of our sales time – maybe 100% – addressing the customer’s most urgent needs.
I never would have believed that you could forge strong customer relationships via video call, but experience has proved me wrong. I’ve learned that a Zoom meeting is still a face-to-face meeting – in fact, our faces seem closer than in a spread-out conference room.
It’s much easier to share visuals and collaborate during a video call: Click to share the screen and everyone can read it without squinting. The customer wants to add something to the agreement? Just type it in. It’s also easier to get decision-makers together at one time, sometimes at short notice, because no one needs to commit to travel time.
In the future, we’ll use in-person meetings more selectively. We’ll find that sales reps are more effective than ever because they spend less time in airports or behind the steering wheel and more time face-to-face with customers.
Agreed?
Year-End Reality Check
Mark Zacur, Executive vice president and chief commercial officer
Owens & Minor
Comment/Observation
On-site meetings with customers became less frequent in 2020, but communication between reps and customers actually increased. This flexibility and collaborative approach to doing business will continue as we navigate the next phases of our collective response to COVID-19.
At the very beginning of the pandemic, Owens & Minor took swift action to protect our teammates and ensure business continuity for our customers. This included implementing product allocation protocols that ensured we were able to maintain continuity of supply for our customers.
Agreed?
Jos Roach, Senior account manager
Concordance Healthcare Solutions
Comment/Observation
Because of COVID-19, I have become better at challenging suppliers a bit differently. What we thought were the main sources of a lot of these challenging products, e.g., PPE, were not necessarily the owners of the supply channel. It forced me as a representative to be open to finding any and all supply chains necessary to keep hospitals supplied.
During the pandemic, many providers have lost tens of millions of dollars due to the reduction in elective surgical cases. They will be looking at their distributors and manufacturers for answers. The challenge will be finding costsavings in an environment where margins have already been reduced over years of cost-savings initiatives.
Regarding work/life balance, sales reps have to consider their own mental and physical health. If they don’t, they’ll potentially end up reducing their ability to serve their customers.
Agreed?
Mina Rezk, Vice president, Midwest, physician office sales
Medline Industries
Comment/Observation
2020 has allowed all of us to improve in our professional and personal endeavors. [Virtual calls] are a culture change for many of us who are accustomed to in-person interactions, but with proper time management, we can reach more customers, expand our product knowledge and become a more vital resource to our evolving market.
I don’t believe [virtual calls] will permanently replace the need for physical interactions, especially during consultative appointments or product demonstrations. While a video can help communicate the use or need for a product, many customers prefer to physically see, measure and test certain investments.
COVID-19 may present more opportunities for physicians to manage their patients’ vitals remotely. There is always the question of compliance and accuracy, but that will continue to improve.
Agreed?
Richard Bigham, director of sales
Atlantic Medical Solutions
Comment/Observation
Most reps have been required to become adept at communication skills other than face-to-face. Adoption of technology along with increased urgency have drastically altered established routines.
Agreed?
With the onset of product allocations, account management skills proved more valuable than selling skills. Successful reps truly understood the needs of their customers and sought products to meet those needs, many times suggesting alternative solutions to them. Communication skills, whether delivering good or bad news, have become more important than ever.
Rep efficiency will continue to improve with the reduction of travel time. Concise communication will boost productivity while improving customer satisfaction.
Face-to-face time with customers will focus on sales rather than account management. Successful reps will evolve to much more of a consultative sales role.
Mark Morauske, Advanced Product Specialist
McKesson Medical-Surgical
Comment/Observation
In the environment of COVID, reps have had to pivot and more frequently use technology like Webex, Zoom, etc., as many customers don’t want in-person visits.
2020 has been a very fluid year, and reps have had to learn how to quickly operate in an environment where new products and testing devices/solutions for COVID have been hitting the market at a rapid pace.
Because most products around testing and PPE have been in short supply, reps have had to hone their customer service skills. Dealing with allocations, keeping customers informed, and helping them find alternative solutions have become a way of life over the last 7 months.
Moving forward, reps will be much more proactive with their customers and help them plan how they are going to keep critical supplies stocked.
Agreed?
Solving customer problems utilizing distributor and manufacturer partnerships
Many distributors and manufacturers want to be superheroes to their customers, solving problems no one else can.
In reality, when we talk to providers about solving a problem, it often involves multiple teams. A collaboration between the distributor, the manufacturer, and the end-user is critical to ensure that the customer has the best experience.
Here are three real-life stories where a good partnership between the distributor, the manufacturer, and the provider made the difference in getting the problem solved effectively and efficiently.
Outfitting a new OR with Supply Carts and Cabinets
The problem: A healthcare system in Massachusetts needed to remodel their ORs. All open storage had to revert to closed storage. The solution: The CME and Metro account managers met with the Sr. Project Manager for Facilities Planning and the OR staff to review the needs of the facility. The team then reviewed current solutions and brainstormed for new ideas and solutions to meet the new requirements. This included a walk through the space to make sure all the customer needs were being met. Metro provided drawings of the new carts and cabinets, which included Starsys, Flexline, and wire shelf equipment. The CME account manager distributed the drawings
and continued to follow-up with the end-users to answer questions, make any changes, and supply detailed quotes for the new equipment. The plans ended up fitting the needs of the client, and CME and Metro partnered to create a new OR storage area to meet the exact needs of the client.
Replacement Carts Customized for Efficiency
The problem: A national healthcare system replaced legacy specified carts in Washington State. The original carts were not connected with viable part numbers and were no longer available from the manufacturer. The customer had no resources to assemble these carts and get them to the appropriate rooms.
The solution: The CME account manager worked with the customer’s equipment planner to get physical photos of existing carts, descriptions of the carts, and the end-user’s current requirements. There were four different types of carts with various levels of accessorizing needed. CME worked with the Metro account manager to configure the carts based on Metro’s offerings, and that met the customer’s specifications. CME built a database of new Metro drawings cross-referenced with the customer’s old carts, including the components in each cart. Each cart was given a unique CME part number that included all of the elements so that the carts could be ordered from CME with one-part number instead of 10, which really helped simplify the ordering process. All the parts were ordered and shipped to the local CME warehouse. To address the customer’s resource challenges, CME assembled and then delivered the carts to the customer built and ready for use.
Carts Need Immediate Repair
The problem: A major health system in Florida had three aging carts that were not locking correctly and needed to be repaired ASAP.
The solution: CME is one of the few on-call organizations certified and trained to repair Metro carts. CME acknowledged the request for service same day and dispatched their Florida-based biomedical technician to the site to determined what was causing the issue with the carts. Armed with the information obtained by the CME technician, Metro sent the needed replacement parts, and the CME technician was able to go onsite to install those parts to fix the locking function on the carts.
With timely service and efficient processes, the partnership between distributors & manufacturers is a significant aspect of the customer experience. By nurturing the partnership with Metro and CME, both companies can provide a better customer experience. In every instance, customers benefit.
CME Corp (CME) is a distributor that focuses on equipment only. Our mission at CME is to help healthcare facilities nationwide reduce the total cost of the equipment they purchase and make their equipment specification, installation, maintenance, and disposition processes more efficient. CME carries over 2M items from more than 2,000 manufacturers and offers customized services that include direct-to-site delivery, biomedical, technical and disposition services.
For over 80 years, Metro has been the world’s leading manufacturer of storage and transport equipment. From our innovative wire and polymer shelving lines to the revolutionary Starsys product line to a broad range of healthcare cart solutions including the Lifeline emergency cart, Flexline procedure carts and Lionville series medication carts, Metro puts space to work in healthcare facilities of all sizes.
No primary care physician is an island …
… particularly those in physician-led ACOs
Editor’s note: The following is second in a series about changes occurring among primary care physicians.
Notice anything different about your physician customers these days? Are they thinking more strategically, perhaps?
Taking on a little risk? Collaborating with others, including social workers, nutritionists, physical therapists or mental health professionals? Complaining a bit less about EMRs and analytics? If so, they may be part of a physician-led accountable care organization, or ACO.
ACOs are groups of doctors, hospitals, and other healthcare providers who join together to give coordinated, high-quality care to Medicare patients, according to the Centers for Medicare & Medicaid Services. Their common goal is ensuring that patients get the right care at the right time – cost-effectively, of course – while avoiding duplication of services and preventing medical errors. Those that succeed share some of the savings with the Medicare program.
From 2010 to 2015, hospitals or health systems sponsored the majority of new ACOs. But in recent years, the ACO market has seen a shift, as physician group organizations have begun to lead the majority of new ACOs. In 2018, physician-group-led ACOs represented approximately 45% of all ACOs, hospital-led ACOs accounted for approximately 25%, and joint-led ACOs represented 30%. Experts believe there is greater market potential for new physician-led ACOs than for those led by hospital systems.
COVID-19 has been a big driver, according to David Muhlestein, chief strategist and chief research officer, Leavitt Partners. During the pandemic, practices that were dependent on fee-for-service saw dramatic drops in patient volume, and hence, revenues, says Muhlestein, who focuses on healthcare payment and delivery transformation. But those that were paid on another basis, such as value-based care, didn’t suffer so much. “The difference in the two types of payments is like the difference between getting paid on commission or salary. Commission is great so long as sales are coming in, but if there’s a downturn, salary can be really valuable.”
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Size doesn’t really matter “Low-revenue” ACOs, as physician-led ACOs are Muhlestein says physician-led ACOs may include as increasingly referred to, have performed better than few as 15 physicians or as many as a thousand or more. “high-revenue” ACOs, that is, those led by hospitals Most commonly, however, they tend to be in the 50-to- and health systems, points out CMS Administrator 100-physician range, he says. Seema Verma. In 2019, low-revenue ACOs had net “Some are in the same market as per-beneficiary savings of $201 large hospital systems, some are in compared to $80 per beneficiary rural areas, and some are in mid-size For physicians, savings for high-revenue ACOs. markets where there are no other ACOs. All it takes is someone to say, it’s moving away The trend is the same for ACOs in the new Pathways to Success pro‘We want to take care of patients dif- from, ‘I am taking gram, in which low-revenue ACOs ferently, and now there’s a payment model that can accommodate that.’” care of this patient had net per-beneficiary savings of $189 while high-revenue ACOs Third-party companies, referred to in front of me,’ to ‘I had net per-beneficiary savings of as ACO enablers, have arisen to help physician groups manage risk, that is, need to be aware $155. (Introduced in December 2018, Pathways to Success reduced balance the financial and care-delivery components of an ACO. of everything the amount of time an ACO could remain in the program before Kim Harmon, vice president about this patient, accepting financial risk along with for ACO services for TMA PracticeEdge, a subsidiary of the Texas and if he or she potential shared savings.) Two factors favoring physicianMedical Association, notes that has needs I can’t led ACOs are market size and potenits client base represents solo and small physician practices who pro- provide for, I tial, says Muhlestein. Simply put, physician groups outnumber health vide care in their local communities. need to create systems, and enjoy many more market “While ACO size varies, 50 to 150 physicians will typically generate the partnerships or opportunities. In addition, physicianled ACOs achieve significant cost-sav5,000 to 7,000 patient lives required arrangements with ings by reducing inpatient admissions. by payers for participation in a con tract,” she says. - other providers.’ On the other hand, health-systemled ACOs, whose inpatient facilities
Lessons learned
Repertoire asked Kim Harmon, vice president for ACO services for TMA PracticeEdge, a subsidiary of the Texas Medical Association, about lessons the organization has learned – and the biggest surprises it has encountered – while forming and nurturing physician-led accountable care organizations. She listed three:
1. Smart growth is
important. An ACO doesn’t need every physician in the community to participate. Focus instead on those who are engaged and willing to learn from the data provided.
2. Success in value-based care models takes time.
Physicians get frustrated when they don’t see immediate results/ rewards. Shared-savings contracts are paid out 6-8 months after the end of the performance year. The longer physicians participate, the better they become.
3. The biggest surprise has been the number of emergency visits generated by conditions that could easily be treated in a primary care practice.
Many patients do not take the time to establish a medical home. When unexpected health issues arise, they feel compelled to visit hospital emergency departments for a quick (and expensive) fix.
still collect revenues based on admissions, may hesitate to do the same.
No physician ACO is an island
In order to provide the total continuum of care for patients, physician-led ACOs must build relationships with other providers. “Physician-led ACOs are responsible for the cost of care at the global level even though they’re unable to directly provide it,” says Muhlestein.
Harmon points out that TMA PracticeEdge’s ACOs are composed solely of primary care physicians who serve as medical homes for their patients. “But that doesn’t mean they are an island,” she says. “They identify specialists in their areas who are good communicators and provide cost-effective and quality care. Preferred urgent care centers help them offer after-hours care, and independent hospitalists manage care in the inpatient setting. Around all of this is a group of care coordinators who help with care transition and checking in on patients between office visits.”
Josh Seidman, managing director, Avalere, says that some large practices already include a number of specialists, while others contract with a select set of specialists for particular issues that commonly arise among their patients. Such specialists, e.g., cardiologists or psychiatrists, might spend one or two days a week in the practice, or are just a telehealth visit away, says Seidman, who advises clients on value-based care models with a focus on information technology. Some ACOs form relationships with hospitalists to oversee the care of patients when they are in an inpatient facility or to stay in touch with emergency department physicians when patients are in hospital EDs. The success of these systems rests on good data exchange between the hospitalist and the ACO, including admission/discharge/transfer (ADT) data.
The long run
Culture change like this doesn’t happen overnight.
Historically, physicians haven’t been trained to proactively identify patients with needs and figure out how to address those needs in advance of them flaring up, says Seidman. “It’s a big shift in approach. Then there is this idea of physicians operating as a team. Even more important is each person understanding their role within that team.
“Physicians aren’t necessarily the best-equipped people to figure out how to help people adopt more healthy behaviors or how to meet a wide array of their social or other needs that have an impact on health,” he continues. “A social worker, health coach or community health worker might be in a better position to do so. Physicians are trained to deal with complex clinical matters, but they have to think about the overall needs of the patient, some of which can be addressed by other professionals.”
Medicare data shows that experience matters, says Seidman. “Physician-led ACOs do better over time – not surprising for anything that requires significant effort.”
Will ACOs, like many healthcare trends, such as HMOs – be relegated to the ash heap of history? How long can they deliver savings and improve quality of care?
“There definitely are things you might call lowhanging fruit in terms of reducing unnecessary hospitalizations and readmissions,” says Seidman. “But shifting your approach in how care teams are organized and social needs are addressed is important for long-term improvements in efficiency and quality.”
ACOs may very well succeed where HMOs didn’t, says Muhlestein. Unlike HMOs, ACOs offer patients the flexibility to switch providers. Even more important, HMOs focused almost exclusively on reducing the cost of care, which meant gatekeepers, prior authorizations – in a nutshell, barriers to care. While ACOs share concerns about cutting costs, they also work to meet goals for quality-of-care and patient satisfaction.
“If you move away from shared savings models to full delegated risk capitated payment, you can perpetuate these programs,” he says. “Physician groups are starting to accept risk. It’s not for everyone; it’s a dramatically different approach to care. For physicians, it’s moving away from, ‘I am taking care of this patient in front of me,’ to ‘I need to be aware of everything about this patient, and if he or she has needs I can’t provide for, I need to create partnerships or arrangements with other providers.’ It’s management.
“Some have already been successful doing this – enough so that many others are now open to the idea.”
PPE Essentials: Gowns
What reps need to know about different types, requirements, claims and standards of gowns used in medical settings.
By William Bagnasco, ASQ CQA, PMI CAPM, CLSSGB, Director of Quality and Regulatory Affairs, DUKAL Corporation
As the novel coronavirus has spread across the globe, Personal Protective Equipment, also known as PPE, has
become the hottest topic in the medical device industry. Along with the increased demand for PPE, came an influx of new suppliers to the market. As new suppliers emerged, so did the questions related to the different types of PPE and various levels of protection that they offer.
Since the onset of the virus in early 2020, the industry has scrambled to secure appropriate product to meet the needs of healthcare workers required to protect themselves and patients from the spread of infection. This article will focus on the different types of gowns, the requirements and claims associated with level rated gowns, and draw attention to the inconstancies between AAMI’s standards and those of the FDA. from the transfer of microorganisms and body fluids in patient isolation situations,” and “surgical gowns” as “devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.” (21 CFR 878.4040)1 The main difference between an isolation gown and a surgical gown
Types and standards
The American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/ AAMI PB70 describes liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. In 2004, the FDA recognized ANSI/AAMI PB70 as the consensus standard. AAMI PB70 defines an “isolation gown” as an “item of protective apparel used to protect healthcare personnel and patients are the critical zones identified for testing and that the back of a surgical gown may be nonprotective. Whereas the back of a level rated isolation gown must offer full back coverage and have a barrier performance of at least a Level 1.
The ANSI/AAMI PB70 standard has 4 levels of fluid barrier protection, with Level 1 being the lowest level of protection and Level 4 being the highest. The following is a table showing the different levels of rated gowns, test methods, and the anticipated fluid exposure for each performance level.
AAMI PB70 guidelines
ANSI/AAMI PB70
Barrier performance
AAMI Level 1 Test method
Water resistance: Impact penetration AATCC 42
AAMI Level 2
Water resistance: Impact penetration AATCC 42
Water resistance: Hydrostatic pressure AATCC 27
AAMI Level 3
AAMI Level 4
Water resistance: Impact penetration AATCC 42
Water resistance: Hydrostatic pressure AATCC 27
ASTM F1671, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by BloodBorne Pathogens Using Phi-X174 Bacteriophage Penetraction as a Test System
Test definition
AATCC 42
AATCC 42 Measures the resistance of fabrics to the liquid penetration of water by impact Measures the resistance of fabrics to the liquid penetration of water by impact
Requirement
Water impact ≤ 4.5 g
Spray impact ≤ 1.0 g Hydrostatic pressure ≥ 20 cm
AATCC 127
AATCC 42
AATCC 127
ASTM F1671 Measures the resistance of fabrics of the liquid penetration of water by impact under constant and increasing hydrostatic pressures Measures the resistance of fabrics to the liquid penetration of water by impact Measures the resistance of fabrics to the liquid penetration of water by impact under constant and increasing hydrostatic pressure Measures the resistance of materials used in protective clothing to penetration by blood borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Spray impact ≤ 1.0 g Hydrostatic pressure ≥ 50 cm
Pass
Anticipated fluid exposure
Minimal fluid levels
Low fluid levels
Moderate fluid levels
High fluid levels
Association for the Advancement of Medical Instrumenation. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for use in Health Care Facilities. ANSI/AAMI PB70:2012. Arlington, VA: AAMI.
According to the FDA, both surgical gowns and isolation gowns are considered surgical apparel and are covered under the requirements of 21 CFR 878.4040. Gowns that are not intended for use in a surgical setting are Class I devices. They are intended to protect the wearer from the transfer of microorganisms and body fluids in low risk patient isolation situations. This includes both Level 1 & 2 isolation gowns, as well as non-rated isolation gowns. The agency identifies gowns that are intended to be used in surgery as Class II devices which require a pre-market notification. A pre-market notification, also known as a 510k submission, ensures that a device meets specific performance standards, labeling requirements and its intended use by demonstrating substantial equivalence to another device which has been shown to be safe and effective.2 The definitions used in the ANSI/AAMI PB70 standard are inconsistent with those used by the FDA, which has caused confusion in the industry. Unlike AAMI, the FDA considers both the level of barrier protection and the terminology used in the marketing and labeling of the device. In 2015, the FDA issued a guidance document clarifying their approach.
The FDA considers gowns with moderate to high barrier protection (Levels 3 & 4) to be a higher-risk device than gowns that claim minimal or low levels of fluid protection (Levels 1 & 2, and non-rated gowns). The FDA
automatically considers a gown to be a “surgical gown” or “surgical isolation gown” when it has a statement relating to moderate or high-level barrier protection. This means that if a gown is labeled as an AAMI Level 3 or 4, it’s considered a “surgical gown” and is subject to the requirements of premarket notification. This contradicts the ANSI/AAMI PB70 standard that states that surgical gowns can be classified as Level 1-4.3
What does this all mean?
To simplify it, a “surgical gown” that is marketed in the United States cannot claim to be AAMI Level 1 or 2 because using the word “surgical” on the label or in any marketing material implies that the gown is intended for use in a surgical setting. Any gown labeled or marketed with the words “surgical”, “surgical gown” or “surgical isolation gown” is automatically elevated to a Class 2 device, requires a premarket notification and should be identified as either AAMI Level 3 or 4. On the other hand, isolation gowns can be rated AAMI Level 1-4 or they can be non-rated. There are non-rated isolations gowns that offer fluid protection which don’t carry a level rating due to the construction features of the gowns, such as having an open back design and/or sewn seams. Any isolation gown that carries an AAMI Level 3 or 4 designation would be considered a high-risk device and would require a premarket notification.
Now that we have a better understanding of the different types of gowns and the differences between FDA regulations and the ANSI/AAMI standard, we can look at what should be reviewed with regards to claims, prior to purchasing a gown. ʯ Level 1 Isolation Gown: The manufacturer should provide test reports, according to AATCC 42, showing that all critical areas of the gown were tested for fluid resistance and that all test requirements were met. Level 1 gowns offer protection against minimal fluid levels. ʯ Level 2 Isolation Gown: The manufacturer should provide tests reports, according to AATCC 42 & AATCC 127, showing that all critical areas of the gown were tested for fluid resistance and that all test requirements were met. Level 2 gowns offer protection against low fluid levels.
ʯ Level 3 & 4 Gown (Surgical and Isolation):
A copy of the 510k summary should be reviewed to ensure FDA clearance. Level 3 & 4 gowns offer protection against moderate and high fluid levels respectively.
An important thing to remember is that all claims that are made with regards to fluid protection should be made on the final, finished gown including the materials, seams and points of attachment. There are gowns on the market that claim that the “material” is fluid resistant. This is an important factor to consider when trying to select the appropriate gown based on its barrier properties. Having a better understanding of the different types of gowns, the various regulations/standards that cover these gowns and the proper supporting documentation will allow you to select the appropriate gown and ensure that the gown does in fact meet the intended use and labeling claims.
1 Sections 3.13 and 3.31 of the ANSI/AAMI PB 70:2012 (citing 21 CFR 878.4040). 2 https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns#g4 3 Guidance document on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings
