MINNESOTA
SEPTEMBER 2019
PHYSICIAN
THE INDEPENDENT MEDICAL BUSINESS JOURNAL
Volume XXXIII, No. 06
A changing role of pharmacy Collaborating on multiple fronts BY SARAH DERR, PHARMD
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illions of Americans lack adequate access to primary health care, and many are not able to see their clinician on a regular basis due to multiple factors, which may include lack of insurance coverage; social determinants of health that limit transportation, mobility, or flexibility in work schedules; and strained financial resources. For these patients—and patients in general—pharmacists can provide invaluable assistance if they are incorporated into care teams.
Understanding regenerative medicine An effective treatment for orthopedic degeneration BY NATE CRIDER, MD, FAAPMR
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egenerative medicine holds great promise in treating pain caused by orthopedic degeneration, a family of conditions that has previously been treatable only with corticosteroid injections or costly joint replacement. Unfortunately, rapid changes in the field and a lack of clearly defined protocols and definitions has led to confusion about what regenerative medicine is and what it can do for patients. Many people conflate live autologous stem cell treatments with dead-cell amniotic preparations, and others have made unfounded claims about non-treatable conditions that have drawn the attention of Understanding regenerative medicine to page 104
This pharmacist-clinician collaboration is key to providing the best patient care in our changing health care system. Adding a pharmacist to the care team can reduce the risk of adverse drug reactions and can lower costs. By having patients manage chronic disease states with their pharmacists, physicians and other providers are freed up to spend more time with complex patients who truly need their expertise. A changing role of pharmacy to page 124
3 things every Minnesota physician should know about treating chronic pain.
1. Opioids are a problem. They can also be part of the solution. According to the CDC, opioid overdose is now the leading cause of injury-related death in the United States. Yet opioids have a rightful place in treating chronic pain, as some patients achieve life-changing improvement with minimal side effects on long-term opioids. Even at high dosage levels, opioids do not harm the body’s organs, unlike NSAIDS and acetaminophen. And thanks to the micro-dosing capability offered by implanted spinal drug pumps, many of the most challenging cases can be treated effectively without risk of addiction.
2. There is no silver bullet. One of the challenges in treating chronic pain is the patient’s sometimes-overwhelming desire for a silver bullet, a “cure” or a magic button to turn off their pain. While that desire is understandable, in complex chronic pain there is rarely a single perfect answer. At Nura, we’ve
found that a comprehensive approach which addresses the physical and psychosocial components of chronic pain is the best solution. So in addition to earning national recognition for leadership in implantable pain technology, we offer behavioral counseling, physical therapy and opioid management, all designed to help the most challenging pain patients.
3. Learn more about chronic pain while earning CME credits. Together with the Minnesota Medical Association, Nura is sponsoring a Chronic Pain Conference where a variety of specialists will share tools, strategies and expertise on managing pain patients. This year’s CME conference takes place on Friday, November 8, at the Westin Galleria Edina, and will provide new perspectives on providing care in the midst of the opioid epidemic. To learn more about our comprehensive approach to chronic pain or to register for the Chronic Pain Conference, please visit nuraclinics.com or call our Provider Hotline at 763-537-1000.
Edina & Maple Grove | NuraClinics.com | 763-537-1000
©2019 Nura PA
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SEPTEMBER 2019
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Volume XXXIII, Number 6
COVER FEATURES Understanding regenerative medicine
A changing role of pharmacy Collaborating on multiple fronts
An effective treatment for orthopedic degeneration
By Sarah Derr, PharmD
By Nate Crider, MD, FAAPMR
DEPARTMENTS CAPSULES
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MEDICUS
7
INTERVIEW
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Bipartisan strides in health care Tim Walz Governor, State of Minnesota
LEGISLATION 14 Insulin pricing A crisis and an opportunity By Sen. Scott Jensen, MD
CARDIOLOGY 16 Aspirin for primary prevention The message has not changed
WEIGHT CONTROL 18 Bariatric surgery High ROI for severe forms of obesity By Jonathan C. Gipson, MD, FACS
PEDIATRICS 22 Recognizing childhood and adolescent hypertension A new clinical decision support tool By Elyse Kharbanda, MD, MPH, and Heidi Ekstrom, MA
ADMINISTRATION 24 Posting the cost of health care Complicated compliance issues By Nancy F. Nelson, FSA, MAAA
By Russell V. Luepker, MD, MS; Jeremy R. Van’t Hof, MD; and Niki C. Oldenburg, DrPH, MPH
CLINICAL AND NON-CLINICAL CARE TEAMS Improving interoperability
Thursday, November 14, 2019, 1–4 p.m. The Gallery, Hilton Minneapolis | 1001 Marquette Avenue South BACKGROUND AND FOCUS: As health care costs constantly rise, containment strategies involve care teams. Many individuals are now part of every physician-patient encounter. Some are hands-on with the patient, some the patient never sees. New entities become part of care teams, offering services from chronic care management, to behavioral health screening, to care coordination, to coding, charting and much more. With goals of lowering costs, increasing reimbursement, and improving outcomes, clinics can customize teams to individual patient needs. Keeping up with this rapidly evolving landscape can exceed the capacity of many medical groups.
OBJECTIVES: We will examine the diversity of care teams and how they interact. We will explore benefits that could result from improved coordination of these care teams. We will identify the barriers to this improved communication, such as incompatible EHRs and data privacy issues, and ways around them. We will provide examples of successful integration of clinical and non-clinical care teams and a road map for adopting and scaling these models for all elements of our health care delivery system.
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ART DIRECTOR_______________________________________________Scotty Town, stown@mppub.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is PO Box 6674, Minneapolis, MN 55406; email mpp@mppub.com; phone 612.728.8600; fax 612.728.8601. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.
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CAPSULES
UCare caps monthly patient costs for insulin UCare’s final 2020 MNsure Individual and Family plan benefits and rates, filed with the Minnesota Department of Commerce, provides members who have diabetes with financial relief through a $25 cap on monthly insulin costs, effective Jan. 1, 2020. Rounding out UCare’s suite of diabetes services, the cap applies to all insulin covered by the member’s plan and is available with UCare’s current plans and new HSA plans. “As the health plan with the largest enrollment through MNsure, we felt a special responsibility to be part of a solution to this important public health issue,” said Mark Traynor, UCare’s president and chief executive officer. The pharmacy benefit completes UCare’s full slate of diabetes programs supporting optimal health for its members living with diabetes.
The cost relief is made possible by recent IRS guidance allowing coverage for insulin benefits outside of a deductible for certain high-deductible health plans. UCare partnered with its pharmacy benefit manager and insulin manufacturers on a plan to bring down the monthly cost of insulin for members.
MNsure awards 2019-20 navigator outreach and enrollment grants MNsure has announced recipients for the Fiscal Year 2020 Navigator Outreach and Enrollment Grant Program. This year’s 24 grants totaled $4.2 million and will fund 43 organizations across the state. These grants will support targeted outreach to uninsured populations and sustain a robust statewide navigator network to provide application, enrollment, and renewal assistance to Minnesotans who need help.
Over the last year, with the help of a navigator from one of MNsure’s grantee organizations, more than 42,000 Minnesotans found coverage and tens of thousands were helped with other important steps, like reporting changes or renewing coverage. Grantees work to assist communities with all aspects of the application, enrollment, and renewal process, and utilize established relationships with populations facing barriers to coverage. The 24 MNsure grants are split into two funding areas: Geographic Focus Grants totaling $2.9 million to support highly skilled navigator organizations working collaboratively with MNsure to reach the uninsured and support Minnesotans in obtaining and maintaining health insurance coverage. The focus on this grant area is on ensuring statewide access to in-person assistance.
Population Focus Grants totaling $1.3 million to support organizations that have identified populations that face barriers to enrolling in coverage and/or high levels of uninsurance and can demonstrate an ability to effectively reach, enroll, and help renew coverage for the population.
Allina Health introduces star ratings for primary care physicians Allina Health now provides star ratings for its primary care physicians, nurse practitioners, and physician’s assistants. The ratings are compiled by an independent organization from surveys sent to patients who receive care from an Allina Health provider. The star ratings, one to five, show on each provider’s web page, along with written comments survey respondents make. Allina Health is the first health system in the Twin Cities to publish these kinds of ratings.
James likes finding ways to save. So it’s a big deal when he can offer his employees a health plan with a new approach to lowering costs — like giving them flexible out-of-pocket limits on covered care. Now, that’s a win for everyone on his team. Health plans with something for everyone to like. Contact your broker or visit uhc.com/mn to learn more. Health plan coverage provided by UnitedHealthcare of Illinois, Inc. Administrative services provided by United HealthCare Services, Inc. or their affiliates. 8566846.0 3/19 ©2019 United HealthCare Services, Inc. 18-10761-A
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The star ratings are based on responses from patients who are randomly invited to complete a Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CGCAHPS) survey. The CGCAHPS survey is a standardized tool developed by the federal Agency for Healthcare Research and Quality (AHRQ) to measure patients’ perception of care provided by physicians in a clinic or office setting. The ratings are based on six questions assessing how well providers explain matters, listen carefully, provide understandable information, know important medical history, show respect, and spend sufficient time during the visit. Not all providers on the Allina Health website will have a star rating or comments. The system displays ratings for specific primary care providers who have a minimum of 30 completed surveys within a 12-month period. Stars and comments for specialty providers will be added in October 2019. In addition, some providers on the Allina Health website may not have ratings and reviews because they participate in a different survey than CGCAHPS, or they are not surveyed by Allina Health.
enables doctors to assess blood flow to the wound, utilizing real-time information to define treatment plans, optimize patient recovery, and reduce the frequency of complications such as necrosis, infection, partial or total limb amputation, and the need for repeat surgery. “We already know that some diabetic and radiation wounds greatly improve when treated with hyperbaric oxygen therapy,” said emergency physician Thomas Masters, MD. “Having the LUNA diagnostic tool to visualize the results allows us to measure the successful healing process during treatment. Likewise, it can indicate when there’s irrevocable tissue death so unnecessary limb preservation efforts can be avoided.” Procedures with the LUNA System do not involve the potential safety hazards associated with X-ray procedures and traditional contrast agents. Because the dye that’s used is processed in the liver, kidney function is not affected. This is significant for patients diagnosed with diabetes whose kidney function may be at risk.
Health system uses advanced real-time blood flow imaging system
The University of Minnesota was recognized as a Milestones in Microbiology site by the American Society for Microbiology (ASM) for its achievements in the microbial sciences and lasting impact on the field. The microbiology research at the U of M is distinguished by its ground-breaking discoveries of a broad range of microorganisms and their interactions with animal and plant hosts. This year marks the Department of Microbiology and Immunology’s Centennial. Originally known as the Department of Bacteriology and Immunology when it was implemented in 1919, the department has been integral to the medical school ever since. Decades ago, scientists at the
Hennepin Healthcare’s Center for Wound Healing and its Center for Hyperbaric Medicine are now using fluorescence microangiography, a new technology that can assess blood flow in chronic, non-healing wounds and diabetic foot ulcers. Hennepin Healthcare is the first in Minnesota to use the LUNA Imaging System during wound assessment. Healthy blood flow or microcirculation is essential to healing wounds that can result from diabetes, a complication from a recent surgery, or even frostbite. Fluorescence microangiography with the LUNA system
U of M recognized for achievements and impact in field of microbiology
This activity has been approved for AMA PRA Category 1 Credit™ and Minnesota Board of Social Work credit. ACPE contact hours for pharmacists pending.
• Professional: $125 • Resident/Fellow/Student: $25
To register or for more infomation, visit slhduluth.com/umnethics or call 218-249-5139 PRESENTED BY: THE UNIVERSITY OF MINNESOTA MEDICAL SCHOOL, DULUTH CAMPUS IN COLLABORATION WITH OUR PARTNERS. University of Minnesota Medical School, Duluth Campus, The College of St. Scholastica, St. Luke’s, Essentia Health, Wisconsin Indianhead Technical College, University of Minnesota College of Pharmacy - Duluth Campus University of Wisconsin Superior, and Lake Superior College
MINNESOTA PHYSICIAN SEPTEMBER 2019
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CAPSULES
University of Minnesota discovered that the size and shape of bacterial cells varies with the rate and stage of growth, and that changes occur with great regularity and are governed by simple laws. These insights shook the foundations of bacterial classification and are just one example from an extensive list of accomplishments.
Housing support approved as new Medicaid benefit Minnesota seniors and people with disabilities soon will have more help finding and keeping housing, thanks to new services coming to the state’s Medicaid program next year. On Aug. 1, Minnesota received federal approval of housing stabilization services as a basic Medicaid benefit. The new services will be available to seniors and people with disabilities—including mental illness and substance use disorder—who are
homeless, living in institutions, or at risk of becoming homeless or institutionalized. The benefit will start in July 2020. When fully implemented, an estimated 7,600 people will receive these services. In 2017, the Minnesota Department of Human Services asked the federal Centers for Medicare and Medicaid Services to add Housing Stabilization Services to the state Medicaid plan. Most current housing services provide short-term assistance only during a crisis or transition. The new services will increase longterm stability by supporting people to plan for, find, and move into their own homes, while also helping people stay in their own homes in the community. “Far too many people are experiencing homelessness, and there is a lack of housing that’s affordable,” said Minnesota Housing Commissioner Jennifer Leimaile Ho. “This
new benefit will help build a stronger link between where people want to live and the services they need to have stability in their lives.” Advocates will help people with disabilities and seniors find and keep housing, addressing potential challenges such as budgeting, interacting with landlords and neighbors, and understanding leases.
Minnesota identifies severe lung injury cases among teens who vape The Minnesota Department of Health (MDH) is encouraging Minnesota health care providers to be on alert for novel cases of severe lung disease potentially related to vaping and e-cigarette use among teens and young adults. Children’s Minnesota has reported finding four cases of severe lung injury in the metro area potentially related to vaping. These cases are
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similar to lung disease cases recently reported in Wisconsin and Illinois, though it is too early to say whether they are connected. “There are still many unanswered questions, but the health harms emerging from the current epidemic of youth vaping in Minnesota continue to increase,” said Dr. Ruth Lynfield, state epidemiologist and MDH medical director. “We are encouraging providers and parents to be on the look-out for vaping as a cause for unexplained breathing problems and lung injury and disease.” In Minnesota, symptoms have resulted in hospitalizations lasting multiple weeks, with some patients being admitted to the intensive care unit. Product names are unknown. Clinical presentation among Minnesota cases included shortness of breath, fever, cough, vomiting, and diarrhea. Other symptoms reported by some patients included headache, dizziness, and chest pain.
MEDICUS
James Pacala, MD, MS, head of the University of Minnesota Medical School’s Department of Family Medicine and Community Health, has received a fiveyear, $3.74 million Health Resources and Services Administration (HRSA) Geriatrics Workforce Enhancement Program (GWEP) award to improve the health care and health of older adults. Minnesota Oncology has named two of its physicians to key leadership positions. John Schwerkoske, MD, will serve a threeyear term as practice president, succeeding Dean Gesme, MD, FACP, FACPE. Dr. Schwerkoske is board-certified in medical oncology, hematology, and internal medicine, and has been actively involved in clinical research programs. Paul Thurmes, MD, will serve as medical director. Boardcertified in internal medicine, medical oncology, and hematology, Dr. Thurmes previously served as site medical director for the Edina Clinic as well as quality medical director for the practice, and is active in providing patients access to clinical trials.
Osmo Vänskä /// Music Director
Leila Josefowicz Plays Stravinsky Nov 1–2
Vaughan Williams’ Dona Nobis Pacem Nov 14–16
Kirsten Indrelie, MD, an obstetrician and gynecologist, has joined the Essentia Health–Duluth Clinic. Dr. Indrelie earned a medical degree from the University of Minnesota Medical School in Minneapolis. She completed a residency in obstetrics and gynecology at Tulane University in New Orleans, LA. Nicholas Lesmeister, MD, an orthopedic surgeon, has joined Essentia Health St. Joseph’s–Orthopedics Clinic in Brainerd. Dr. Lesmeister earned a medical degree from the University of Minnesota Medical School in Minneapolis, where he also completed a residency in orthopedics.
OS M O VÄ N S K Ä
Joshua Kropko, DO, has joined St. Luke’s P.S. Rudie Medical Clinic in Duluth. Dr. Kropko received his medical degree from Lake Erie College of Osteopathic Medicine in Erie, PA, and completed his residency in family medicine at the Duluth Family Medicine Residency Program. He is certified in family medicine. Also joining the clinic is Christine Ripp, MD. She received her medical degree from the University of Wisconsin School of Medicine and Public Health and completed her residency in family medicine at the Allina Health United Family Medicine Residency Program in St. Paul. Dr. Ripp is certified in family medicine.
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MINNESOTA PHYSICIAN SEPTEMBER 2019
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INTERVIEW
Bipartisan strides in health care Tim Walz Governor, State of Minnesota During your first term as Governor, you worked with a divided Legislature. What can you tell us about drawing both sides to the table?
New legislation will also address mental health on several fronts. Please describe these.
Mental health care is health care, and I’m committed to making sure that mental health care services are affordable and accessible across our state. One achievement I’m proud of is increasing the mental health services available to our farmers, who are facing incredibly challenging environmental and economic conditions.
From the beginning, I said that I wanted to do things differently than what’s happening at the federal level. I worked with the Speaker and the Majority Leader to set benchmarks for when we wanted work to be done, and we committed to building our relationships over the course of the legislative session. When it came to negotiations, we were able to come to the table in good faith and have honest conversations because of the work we had done up to that point.
In the face of GOP opposition to new taxes, the Legislature renewed the provider tax at a reduced rate of 1.8%. How will this benefit all Minnesotans?
The provider tax directly impacts the one in five Minnesotans who rely on the health care access fund. Without the provider tax, many lowincome and vulnerable Minnesotans would have to go without reliable, comprehensive health care through Medical Assistance and MinnesotaCare. The benefits of the provider tax go beyond just those Minnesotans receiving health care through Medical Assistance and MinnesotaCare. When patients are uninsured or underinsured, they don’t stop experiencing health concerns— they just go without regular or preventative health services, resulting in costly emergency room services or long-term care for what might have been a treatable condition. This leads to poorer health outcomes and higher costs for all patients and providers, which is why we saw hospital leaders and health care providers from across the state calling for an end to the sunset on the provider tax.
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SEPTEMBER 2019 MINNESOTA PHYSICIAN
“...”
It is unacceptable that Minnesotans are being denied life-saving drugs like insulin.
“...”
No one got everything that they wanted, but we got a budget done without shutting down the government or resorting to name-calling. Minnesota is showing the rest of the nation that Republicans and Democrats can still find compromise and work together.
Despite partisan disagreements over elder care regulations in the 2018 session, lawmakers this year reached agreement. Please highlight the gains for older Minnesotans.
In recent years, we’ve seen some truly heartbreaking reports of the abuse and neglect experienced by Minnesota seniors in our assisted living facilities. No Minnesotan or their family should have to worry about their safety when putting their trust in an assisted living facility, and the Legislature came together to create increased protections. Now, assisted living facilities must be licensed to ensure they are safe and high-quality care centers, and residents have increased protections, including the right for them or their family to install a camera in the resident’s room, should they suspect that abuse or neglect is taking place. In creating these requirements, Minnesota joins the other 49 states in ensuring this important protection for those receiving assisted living services.
Significant investments in the 2019 session will make the behavioral health system more sustainable and fill gaps, while new resources will help Minnesota respond more effectively to behavioral health needs statewide. The state will continue to build on the success of Certified Community Behavioral Health Clinics, expanding the number of one-stop shops that combine mental health care and substance use disorder services. Changes to the behavioral health care funding structure will bring in more federal money, while reducing the financial burden on counties and making services more readily available when people leave residential treatment. Other investments will expand the state’s capacity to serve children who need intensive mental health care and give more children access to school-linked mental health services. A new opioid fee will raise money to improve and expand opioid treatment and prevention services, reducing the burden of the crisis and expanding access to culturally specific care for disproportionately affected tribal communities. The budget also invested in a comprehensive, community-based suicide prevention program that builds upon a public/private partnership to expand, strengthen, sustain, and support community-based suicide prevention across Minnesota. How will increased fees on prescription drug manufacturers and distributors benefit the state’s efforts to address the opioid epidemic?
The opioid crisis has devastated every corner of our state, and there isn’t a one-size-fits-all solution for every community. The fee on prescription drug
manufacturers and distributors creates an opioid stewardship fund, which can then be used to fund innovative and effective services from local providers who are on the frontlines of this crisis. The fund will also alleviate the costs that counties and municipalities face when dealing with the consequences of this crisis. Please describe legislative initiatives regarding pharmacy benefit managers (PBMs).
I signed bipartisan legislation this year that will require pharmacy benefit managers to be licensed in order to do business in Minnesota. This effort aims to lower the cost of prescription drugs for Minnesotans, provide better transparency to consumers and pharmacists regarding PBM business practices, and improve Minnesotans’ ability to shop for lower-priced pharmaceuticals. Among the bills that failed to pass in 2019 was one that would have provided insulin to uninsured people with diabetes. Will you continue to push for initiatives to reduce the cost burdens of this and other prescription drugs?
Yes. It is unacceptable that Minnesotans are being denied life-saving drugs like insulin, drugs that have not substantively changed for decades
yet have risen in price. People are dying from rationing or going without insulin. I know the Legislature has come up with a few solutions. As soon as they decide on a path forward, I am ready to pass this bill, sign it into law, and save lives. What can you tell us about the future of reinsurance and a consumer buy-in option to MinnesotaCare?
My proposed budget included several alternatives to reinsurance that would have provided more relief directly to consumers. However, as part of the compromise with Senate Republicans, reinsurance was extended for two more years. I will continue to advocate for health care initiatives that provide relief directly to Minnesotans, and that includes providing additional, comprehensive health care coverage options through the ability for Minnesotans to “buy-in” to public health care options. What else would you like to share with Minnesota health care professionals regarding the 2019 session?
people who are directly impacted and do this work every single day. Your voices made a difference, and I look forward to your continued advocacy. Former Gov. Mark Dayton was a strong advocate for health care. What initiatives of his will you continue to advance during future sessions?
Every Minnesotan deserves access to quality health care at a price they can afford, and providing access to affordable health care was a key part of the first budget we proposed. My proposal included funding to extend low-cost coverage to thousands of farmers, small business owners, and entrepreneurs. The budget proposals also would have provided every Minnesotan with an additional health care option, encouraged stability in the individual market, and made health care more affordable in Minnesota. I will continue to advocate for these priorities in future legislative sessions. Tim Walz is Minnesota’s 41st Governor. His career has been defined by public service, from serving
I’d like to thank the health care providers who traveled to the Capitol, sometimes from great distances, to share their expertise and experience. Good bills get passed when lawmakers hear from the
our country in the military, to serving students as a high school teacher and football coach, to serving in Congress on behalf of Minnesota’s First Congressional District. In 2018, he was elected as Governor.
MEDICAL MALPRACTICE ATTORNEYS
Angela Nelson
Matthew Frantzen
Ryan Ellis
Marissa Linden
Jennifer Waterworth
Tracy Jacobs
MINNESOTA PHYSICIAN SEPTEMBER 2019
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3Understanding regenerative medicine from cover the FTC. But despite these “bad actors,” there are many more well-trained physicians performing high-quality, image-guided, evidence-based, FDAcompliant regenerative procedures, effectively reducing pain without the need for surgery. This article will attempt to clarify the various boundaries and tiers within regenerative medicine, and to demonstrate the cutting edge of this exciting field.
Regenerative medicine has become synonymous with stem cells in the public’s mind, but Platelet Rich Plasma (PRP) procedures are far more commonly used, are less invasive, and are supported by a larger evidence base. Most cases of mild-to-moderate osteoarthritis, tendonitis, or partial thickness tendon tears, fasciitis, and ligamentous laxity or strain can be effectively treated with PRP.
Harnessing natural responses
Platelets are fragments of megakaryocyte cells which do not contain nuclei and are therefore Definitions unable to divide, but which are primed to release PRP treatment of chronic injuries Regenerative medicine refers to therapies that harness growth factors that can orchestrate repair. PRP is simply re-starts an acute repair. the patient’s own cellular healing response to repair a concentrate of platelets derived from the patient’s a painful and degenerated tissue in vivo. While it own blood, which is then re-injected into the may one day be used to regrow cardiomyocytes or precise area of degeneration, typically into a tissue neural glia, at this time the only FDA-compliant with poor innate bloodflow. Upon injection, the and evidence-based use of these cell-based therapies platelets degranulate and cause a temporary spike in in the clinic is for orthopedic degeneration. There inflammation and pain. Platelet-derived cytokines has been an explosion of “stem cell clinics” in Minnesota and around the stimulate native stem cells to bring about repair and increase blood flow to country, many of which make broad claims about incurable neurological bring circulating progenitor cells to the area. conditions. Such clinics have defied FDA regulations and continue to This is the same response that the body mounts to any acute injury, market with impunity, believing they are too numerous for the FDA so PRP treatment of chronic injuries simply re-starts an acute repair to effectively police. However, recent actions against two large clinic when the initial response was inadequate. For instance, a chronically chains—US Stem Cell, Inc., and Cell Surgical Network—highlight the loose ankle moves beyond its healthy range of motion and risks FDA’s dedication to protecting consumers while supporting the ethical and developing post-traumatic arthritis. Similarly, a whiplash injury in the compliant use of orthobiologics. spine can strain the posterior ligaments and allow excessive movement between the vertebrae, movement which shears on disks, jams facet joints, and causes paraspinal muscles to spasm in an attempt to provide stability. The ability of platelets to tighten ligaments and repair tendons thus makes it a useful tool for treating subfailure instability, which would otherwise accelerate wear-and-tear. Stem cells have gotten more of the press for their unique ability to differentiate into the target tissues, allowing us to fill larger cartilage defects or tendon tears with progenitor cells. Their mechanism of action, however, likely extends beyond simply becoming the target tissue, as results are often seen just weeks after injection with relatively mild changes on imaging. Cytokines released by stem cells can have paracrine effects which stimulate local cells to divide or modulate inflammatory pain signals. Mesenchymal stem cells (MSCs) have also been shown to donate healthy mitochondria to native cells whose mitochondria are damaged, another possible mechanism for their therapeutic effect. It should be noted that no groups are using embryonic stem cells, an ethically fraught tissue whose controversy became irrelevant once pluripotent adult mesenchymal stem cells were discovered. It becomes necessary to consider FDA regulations when working with human tissues, as outlined in FDA Regulation 21 CFR 1271. While the FDA regulates food, drugs, and devices, they have determined that use of a patient’s own tissue—such as with PRP, bone marrow concentrate, or autologous fat graft—falls under “practice of medicine” if it is compliant with three criteria: same-day procedure, homologous use, and minimal manipulation. Conversely, if one were to store a patient’s cells for another day, use them for purposes the cells do not naturally perform in the body, or manipulate those cells outside the body, it would be as if the practitioner were manufacturing a drug, which would be regulated as such by the FDA. Autologous Bone Marrow Aspirate Concentrate (BMAC) is “FDA Compliant” for homologous use in orthopedics
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SEPTEMBER 2019 MINNESOTA PHYSICIAN
and has been used clinically since 2005. The mesenchymal stem cell fractions of the bone marrow can be concentrated and purified without manipulating the cells, making a same-day reinjection of BMAC FDA-compliant. Most systems that process adipose tissue require enzymes to digest mesenchymal stem cells away from the fat (stromal vascular fraction, or SVF), which the FDA has said constitutes more than minimal manipulation. Both clinics cited above were sued by the FDA for using SVF—which is more than minimally manipulated— for purposes that were nonhomologous, such as the treatment of neurologic conditions.
osteoarthritis. In the spine, platelet lysate (PL) epidurals have been able to effectively treat radiculopathy and support resorption of bulging disks. In disks that do not respond to PL epidurals, intradiscal injection of BMAC is another therapeutic option before resorting to discectomy and fusion.
Documenting results
As physicians lead the way on developing protocols and uses for orthobiologics, it is also our responsibility to follow and publish our results. Regenexx has been doing this since 2005, and our registry now includes over 91,250 regenerative procedures whose results are publicly Providers both can and must More often than not, treatments advertised available online. Multiple early studies had conflicting work together to minimize as stem cell therapies actually fall into a third results, often using different PRP preparations that cost and duration of care. category, which are amniotic or placental tissues. In failed to remove inflammatory leukocytes and/or red comparison to autologous bone marrow concentrate blood cells, had varying or unreported concentrations or fat graft, these are allogenic tissues—donated of platelets, or had insufficient follow-up. The more byproducts of the birth process which are then recent research using modern preparations of PRP have processed in a centralized facility, freeze dried, and supported its use in most orthopedic settings, although irradiated for safety and transportation. When they are still limited by small sample sizes. Most of the multiple independent labs have attempted to grow stem cells out of these larger studies on regenerative medicine have been prospective registry datasets products, they have been found to have no viable cells. There have also been due to practical difficulties in designing and financing more powerful studies. several cases of infection from amniotic products, and concern of immune Unlike a pharmaceutical company that owns exclusive rights to market incompatibility has been raised. Extracellular matrix proteins and low levels the final product, personalized cellular therapies are decentralized and of growth factor may explain some of the positive effects of these treatments. without a single stakeholder to finance a multimillion-dollar study. It is Unfortunately, many sales reps and the providers they’ve sold to continue to refer to these as “stem cell treatments,” despite the lack of viable cells capable Understanding regenerative medicine to page 344 of self-replication or secretory functions.
Developing a treatment plan Once a regenerative medicine physician has decided on the appropriate biologic therapy and desired concentrations, the next consideration would be which targets to inject. Unfortunately, some providers in this space are not trained musculoskeletal injectionists, and instead perform intravenous infusions as a treatment for peripheral joint pain. Following IV delivery, 95% of those cells would be trapped in the lung at first pass, and only a small fraction of the remaining 5% would reach the target joint. MSCs adhere and differentiate based on their surroundings, so it is essential that they be delivered directly onto the cartilage defect or into the visualized tendon tears. This requires image guidance—typically ultrasound for soft tissue and fluoroscopy for spinal joints or more difficult joints. The Interventional Orthopedics Foundation (IOF) is a nonprofit dedicated to research and education in this field, helping to define the skillset necessary to carry out a comprehensive and precise nonsurgical regenerative treatment. The American Academy of Orthopedic Medicine (AAOM) and The Orthobiologic Institute (TOBI) put on similar workshops and cadaver courses for physicians looking to improve their musculoskeletal injection skills. As the regenerative physician develops his or her skills with ultrasound and fluoroscopy, additional targets become available, making interventional orthopedics a subspecialty truly distinct from sports medicine or interventional pain. Some of the more advanced treatments include fluoroscopy-guided injections of MSCs into both bundles of the anterior cruciate ligament (ACL) in select cases of ACL tears, which has helped athletes return from complete tears with normal ligament function and MRI appearance. We can also perform subchondral bone augmentation with BMAC to treat osteonecrosis or bone marrow edema in cases of severe
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3A changing role of pharmacy from the cover
providers, order laboratory tests, and adjust medication through adding, changing, and discontinuing medications.
An evolving field
According to a study in the United Kingdom, 5% of emergency The pharmacy profession has evolved greatly over the course of the last department presentations, and 13% of presentations to general practitioners, two decades. Pharmacists remain committed to represent minor ailments that could be managed in providing information and access to prescription community pharmacies. Another study evaluated medications for patients; however, their scope of the effects of pharmacist care on heart failure, a practice now also includes health wellness testing, leading cause of hospitalizations. One review of chronic disease management, and medication 2,000 patients from 1998 to 2007 found a 29% Pharmacist-run services saved management services. Additionally, Minnesota reduction in all-cause hospitalization and a 31% $647,024 by preventing pharmacists can administer most vaccinations, hospital admissions and reduction in heart failure hospitalizations. and recent legislation will allow pharmacists emergency department visits. New roles for the pharmacist to administer subcutaneous and intramuscular Some examples of current pharmacy practice areas: medications in the pharmacy to assist with mental health and opioid/alcohol use disorder. Inpatient care. Currently, inpatient pharmacists Pharmacists can be found in nearly all practices of health care, including, but not limited to, inpatient and outpatient care, community and chain pharmacies, long-term care, specialty medication practices, toxicology, and nuclear pharmacy. Pharmacists act as a part of the patient care team by assisting other health care professionals to ensure each medication a patient takes is indicated, effective, safe, and convenient. Pharmacists are well versed in preventative care, patient counseling, motivational interviewing, and health and wellness. They know how to manage chronic diseases such as hypertension, diabetes, and hypercholesterolemia. Pharmacists can manage treatment plans initiated by
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serve on the health care team to review medications on rounds and make suggestions regarding patient care. Additionally, they provide patients and providers with information about medications and check for drug-drug, drug-food, and drug-disease interactions. Challenging medications—for example, antibiotics such as gentamicin and vancomycin— require difficult dosing calculations, which pharmacists can assist with to ensure patient safety. In response to a rise in strains of antibiotic-resistant bacteria, pharmacists in the inpatient setting have stepped into antimicrobial stewardship. By creating a plan and an antibiogram (which shows the hospital’s history of which microbes have been resistant to which antibiotics), pharmacists can assist in preventing further increases in bacterial resistance. Additionally, pharmacists serve on the pharmaceutical and therapeutics committee to determine which medications will be on formulary at the health system. This is extremely helpful, as there have been many recent drug shortages and pharmacists are aware of which medications are available. Many pharmacists or student pharmacists assist with medication history at intake and review the medication to ensure that the patient is on the right medications at all stages: what they were taking prior to admission, while they are in the hospital, and before they go home or move to another care center. Ambulatory care. Minnesota is well known for embedding ambulatory care pharmacists within clinics, where they see patients, typically in one-onone interactions. These pharmacists offer medication therapy management services to assist patients in better understanding their medications. These pharmacists spend anywhere from 30–60 minutes with a patient at each visit. They review the full patient medication list and check for indicated, effective, safe, and convenient medications, supplements, over-the-counter medications, and herbals. Additionally, they review the patient’s diagnosis and labs to ensure that medications are working appropriately and to see if any additional therapy is needed. Typically, this is done through a Collaborative Practice Agreement with the physicians, physician assistants, and nurse practitioners practicing in the clinic. Pharmacists can also assist with warfarin and insulin therapy adjustments. One study found that pharmacist-run services saved $647,024 by preventing hospital admissions and emergency department visits. A cost effectiveness evaluation indicated that discharge counseling by pharmacists had a cost savings in 48% of scenarios, but all scenarios were cost effective at a low willingness-to-pay value. High-risk elderly patients appeared to benefit most from this service.
MTMʼs Reduction in Per-Person Health Care Costs Blue Cross/Blue Shield of Minnesota Study Pre-MTM Services $11,965 Post-MTM Services $8,197 $0
$3,000
$6,000
$9,000
$12,000
Figure 1. National Association for Chain Drug Stores. Pharmacies: Improving Health, Reducing Costs.
A study of medication therapy management programs with 186 patients through Blue Cross and Blue Shield of Minnesota found reductions in health care costs per person of 31.5%, from $11,965 to $8,197. Prescription claims increased 19.7%. The total cost of medication therapy management services was estimated at $49,490, but total health care expenditures for
all patients were reduced by 31.5%, from $2,225,540 to $1,524,703. The return on investment was $12.15 per $1 of MTM services provided. This cost reduction can be seen in Figure 1. Community. Community pharmacists can also assist with chronic disease management and reviews of full patient medication lists, following up on work performed in the ambulatory care setting. Simple lab tests, such as glucose screenings and cholesterol checks performed at the pharmacy, allow patients to check their labs between clinic visits. This can also help flag an issue to share with the patient’s clinician. In-pharmacy blood pressure checks, PHQ-9, and GAD assessments can ensure that the patient’s medication therapy is effective. Pharmacists are also uniquely positioned to assist with the more than 300,000 over-the-counter medications now available. Community pharmacists also play a key role in assisting patients with medication adherence, which correlates with positive health outcomes. It is estimated that 20% to 50% of patients may not be adherent with their medications. Nonadherence is associated with disease progression, therapy failure, and hospitalization. A study found that 33% to 69% of medication-related hospital admissions are due to poor medication adherence. As the patient comes in on at least a monthly basis to refill a prescription, this is a great opportunity for pharmacists to assess adherence, to intervene if there is an issue, and to contact the clinician if there is great concern regarding adherence. On the national level, the Community Pharmacy Enhanced Services Network (www.cpesn.com) offers resources to help pharmacies assess
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A changing role of pharmacy to page 324
Please join us at this one-day CME conference where a variety of specialists will share tools, strategies and expertise on managing pain patients. Individual presentations, followed by a panel discussion, will provide new perspectives on providing care in the midst of the opioid epidemic. Go to nuraclinics.com for agenda and speaker information. Designation of Credit Statement for Jointly Sponsored Activities: The Minnesota Medical Association designates this live activity for a maximum of six point seven five (6.75) AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Register today at nuraclinics.com MINNESOTA PHYSICIAN SEPTEMBER 2019
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LEGISLATION
Insulin pricing A crisis and an opportunity BY SEN. SCOTT JENSEN, MD
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day of reckoning has arrived for Minnesotans. Across the state this question is being asked repeatedly: “Who bears the costs of chronic medical problems able to be successfully treated with life-sustaining expensive medications?” Insulin has become the center point in this discussion regarding the inadequacies in our current health care system. While this is frustrating to some, I believe it presents an opportunity to pivot the conversation towards “who are we and what do we want our health care system to do?”
History For too long, patients suffering from pre-existing conditions have been left alone to navigate the medical maze that accompanies the ownership of chronic diseases such as diabetes, epilepsy, asthma, peanut allergies, and many other maladies. Even though these illnesses can be successfully managed with medications and/or avoidance measures, the journey to find a way to obtain, afford, and manage the necessary prescriptions is an arduous one. A step back in time may be instructive. Fifty years ago, the first human landed on the moon, the Mets won the World Series, the crowds at
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Woodstock dispersed, and health care coverage was expanding rapidly. Four years earlier, the creation of Medicare and Medical Assistance piggybacked on an already expanding employee-based health insurance industry to give rise to a question destined to nag society for decades: “Is health care a right or a privilege?” I believe that in the wake of Obamacare and so many other initiatives, this question now approximates irrelevance. A 30,000-foot view sees an affluent country trying to pivot around the question of responsibility: “What responsibility does society and government have for providing basic health care services to all?” Alongside this question lies a challenge to all citizens to be responsible users of health care services and to recognize that the common good is served best by a restrained appetite for medicines, tests, and professional medical attention. Currently more than 80% of Minnesotans believe that a basic package of health care should be available to all. I agree with this assessment, but I am impressed virtually every day by the challenge of gaining bipartisan consensus to support this viewpoint that society is best served through the provision of medical care for all. The vast majority of physicians agree that creating a universally accessible and affordable first-world health care system will require an underlying social contract between government and its citizens, recognizing that resources have limitations and abuse of consumption can and will undermine the best of intentions. We turn our attention now to the never-ending bickering about what to do with our health care system with all of its myriad problems—lack of access, unaffordable costs, epidemic corporate greed, excessive patient utilization of resources, physician profiteering from the use of low-value services, and so many more abuses. The last eight months may be viewed by many as a distasteful political stew of scheming and backroom machinations devised to blame the “other political party” for not being motivated to solve the insulin price crisis. The end result was predictable: “kick the can” down the road.
Rising price tags A quick summary will refresh our minds with the following facts: an astronomical rise in the cost of insulin products has inflicted catastrophic effects on patients who experience an interruption in their continuous supply of insulin. A perfect storm of adverse marketplace trends has compromised access to affordable insulin, and this very real hardship has now become one of the premiere health care issues throughout America. Rather than go into detail regarding the cost of insulin products, I share one fact: in the last couple of decades a single unit of insulin has gone from a few pennies to almost half a dollar in some circumstances. Insulin is a biologic product and, as such, generating cost-effective biosimilars does not parallel the relatively conventional process of creating inexpensive generic small molecule products. Virtually every primary care physician in Minnesota and many specialists can share numerous anecdotal stories about how their patients have suffered from the exponential rise in the cost of insulin, which
has often led to devastating financial impacts, the interruption of stable health, and even the loss of life. The practice of rationing insulin is not an uncommon response on the part of patients—it has become commonplace and is quite understandable when one considers the complex intersection of needs, wants, dollars, and priorities.
of any inexpensive old-fashioned insulin products delivered by old-fashioned syringes obtained from old-fashioned vials associated with old fashioned costs is second-class care associated with terrible prognoses and likely future loss of limbs or kidneys. Savvy physicians realize that, while insulin analogues contain glitzy bells and whistles, old-fashioned, less expensive human-based products can still do an adequate job in many situations in managing diabetes in accordance with best practice standards.
The pharmaceutical supply chain, with its many twists and turns, contributes mightily to the rising cost of insulin, but the blame game should not be limited to manufacturers, wholesalers, pharmacy Stalled legislation An astronomical rise in the cost benefit mangers (PBMs), employers, insurance My perception of the recent 2019 session of the of insulin products has inflicted payers, or pharmacists. Culpability even includes Minnesota Legislature was unfavorable, as many catastrophic effects on patients. physicians and patients. When physicians prescribe important topics were blocked from committee insulin without specifically addressing the issue of hearings by chairpersons, and a behind-the-scene cost and inquiring as to how the patient will be able triumvirate team—the governor, senate majority to access and afford insulin, they are treating the leader, and speaker of the house canceled out much patient as a mere client or chart number—we can committee policy work done during the first five and must do better for our patients and their families. When patients and months of legislative meetings. Many political pundits termed the session families have a solid understanding of the disease and yet allow an emerging as a “dud” and House Republican Minority Leader Kurt Daudt said this: crisis to become a real catastrophe, they also share the blame by not being “This has been the least productive, least transparent session in the history of more proactive in reaching out to their pharmacist and/or physician. this state. Minnesotans should be ashamed of the process at the end of this Pharmaceutical manufacturers have used effective marketing techniques, including samples, coupons, pharmaceutical representatives, perks, and meals to convince physicians and patients that each and every new product released on the market is better than the last. Marketing initiatives have insidiously and successfully brainwashed too many people into thinking that the use
legislative session.” Nevertheless, one bright spot did occur as a strong pharmacy benefit manager bill was passed and signed by the governor. (I was privileged to serve as chief author.) This legislation focused on PBM licensure, increased Insulin pricing to page 304
MINNESOTA PHYSICIAN SEPTEMBER 2019
15
CARDIOLOGY
Aspirin for primary prevention The message has not changed BY RUSSELL V. LUEPKER, MD, MS; JEREMY R. VAN’T HOF, MD; AND NIKI C. OLDENBURG, DRPH, MPH
T
For patients who may be confused by news headlines regarding aspirin risk—and for the health care providers who treat them—the University of Minnesota’s “Ask About Aspirin” program, part of a multi-faceted public information campaign, provides a wealth of background information, along with an online tool to estimate 10-year and lifetime risks for atherosclerotic cardiovascular disease (ASCVD)
he safety and appropriateness of taking aspirin to prevent a heart attack or stroke has been the subject of debate in recent months. Should aspirin be taken to prevent a first heart attack or stroke? How does one balance the risk reduction for myocardial infarction (MI) or stroke with the risk of bleeding on aspirin? Should aspirin instead be The evidence still supports aspirin’s recommended only for secondary prevention?
What does the 2019 ACC/AHA Guideline say?
The Top 10 Take-Home Messages for the Primary Prevention of Cardiovascular Disease states the following: “Aspirin should be used infrequently in the routine primary prevention of ASCVD because of lack of net benefit.” Many may interpret (and some have interpreted) this statement to suggest that aspirin is no longer effective for the primary prevention of CVD. This is not the case. Rather, the authors use this document to emphasize control of other risk factors such as hypertension and hyperlipidemia while cautioning providers on the risk of bleeding with aspirin. Later in the document, a Class IIb recommendation states that “Low-dose aspirin (75-100 mg orally daily) might be considered for the primary prevention of ASCVD among select adults 40 to 70 years of age who are at higher ASCVD risk but not at increased bleeding risk.”
effectiveness in preventing heart attacks and strokes.
Recent randomized, controlled trials, along with the 2019 Guideline on the Primary Prevention of Cardiovascular Disease issued by the ACC/AHA (American College of Cardiology/American Heart Association), have renewed our focus on aspirin’s utility for primary prevention of cardiovascular disease (CVD). Yet, despite the public and professional media coverage to the contrary, the fundamental message has not changed: Consider low-dose aspirin for primary prevention among adults for whom it is appropriate.
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So what does this mean? It suggests that aspirin can still be effective in preventing heart attacks and strokes among adults for whom it is appropriate. The challenge lies in identification of appropriate patients. This critical decision-making is the reason health care providers are needed to comprehensively evaluate each individual for their risks and benefits, facilitating an informed decision. An algorithm accounting for CVD and bleeding risk is inadequate. The AHA/ACC statement acknowledges that patients with increased CVD risk stand more to gain from aspirin use and that there are relatively accurate tools available to assess risk. Unfortunately, bleeding risk is more difficult to quantify. Due to the complexity of the relationship between CVD risk and bleeding risk, the AHA/ACC abstains from defining a CVD risk threshold to consider aspirin, but they acknowledge that 10% is often used. Furthermore, the authors expand the age window to younger ages compared to other recommendations.
What does the 2016 U.S. Preventive Services Task Force Recommendation Statement say? This task force recommendation is now the third national guideline (2002, 2009, 2016) that endorses the use of low-dose (81 mg) aspirin to prevent a first heart attack or stroke. The 2016 USPSTF recommendation endorses the use of aspirin to prevent a first heart attack or stroke in men and women 50 to 59 years of age (B recommendation) and in men and women 60 to 69 years of age (C recommendation) when the 10-year cardiovascular event risk is greater
than or equal to 10%. This recommendation is clear and remains accurate with the recent publications. The authors again highlight aspirin use only in those who are not at increased risk of bleeding. They also emphasize the importance of shared decision making, noting that some patients may place more value in avoiding myocardial infarction (MI) or stroke and less value in a gastrointestinal bleeding, influencing the risk/benefit threshold one might consider when initiating aspirin.
What do the aspirin randomized clinical trials show?
How does one identify an appropriate primary prevention aspirin candidate?
While the target age groups and ASCVD risk thresholds vary across guidelines and over time, the evidence still supports aspirin’s effectiveness in preventing heart attacks and strokes. The primary question is whether the benefit of averting a potential heart attack or stroke outweighs the harm from a potential bleeding event. Recent clinical trials demonstrate that starting aspirin in elderly The primary question is whether patients (>70 years) may be harmful but should be the benefit … outweighs the harm considered in younger adults.
The 2016 USPSTF recommendation statement from a potential bleeding event. Consider the following when discussing starting on primary prevention aspirin use includes 10 aspirin with your patient for primary prevention: randomized, controlled trials to examine the effectiveness of aspirin for the primary prevention • Patient is at low risk of GI bleeding (no of CVD, involving over 100,000 individuals. history of GI bleeding, daily use of NSAIDs These studies found that aspirin reduces the risk or any other anti-clotting medications). of major CVD events (total MI, total stroke, and CVD mortality) by an • Patient’s ASCVD risk is high (≥ 10% ten year ASCVD risk, average of 11% (RR, 0.89, 95% CI 0.84-0.95). according to 2016 USPSTF recommendation). Since the publication of the 2016 USPSTF recommendation on primary • Patient is between 50–69 years old (2016 USPSTF prevention aspirin, there have been five additional prospective randomized recommendation). controlled trials, adding approximately another 50,000 subjects. These • Patient’s co-morbidities and family history of CVD. include the JPPP (2014), JPAD (2016), ASPREE (2018), ARRIVE (2018), • Patient is not allergic to aspirin. and ASCEND (2018) studies. These studies, when added to previous studies, showed that aspirin was associated with a 15% lower risk of non-fatal MI (HR, 0.85, 95% CI 0.73-0.99), a 19% lower risk of ischemic stroke (HR, 0.81, 95% CI 0.76-0.87) at a cost of increased bleeding (Zheng SL et al., JAMA 2019;321:277-287).
Aspirin for primary prevention to page 214
It is important to point out that two of these five trials enrolled elderly people over 70 years of age (ASPREE=mean age 74 and JPPP=mean age of 71). This is a population group who are not included in the target age groups for primary prevention aspirin use in the 2016 USPSTF and 2019 ACC/AHA guidelines. The ASCEND trial only enrolled adults with diabetes mellitus and the ARRIVE trial enrolled low to moderate risk adults. The authors from the ARRIVE and ASCEND trials did note that most GI bleeding could be easily controlled while the cardiovascular endpoints resulted in significant disability or death. They did not suggest removing aspirin as primary prevention but emphasized the importance of clinician advice.
What the research shows In secondary prevention, there is no controversy: aspirin saves lives. Yet, aspirin may also be effective if we were able to deliver it safely one minute, one day, or weeks prior to a heart attack or stroke. However, there is not a clear distinction between primary or secondary prevention. There is merely a “continuum of risk.” If risk is high enough, aspirin can provide benefit. All individualized cardiovascular prevention requires risk assessment. We effectively and safely lower CVD risk with multi-drug antihypertensive, diabetic, and lipid-modifying treatments every day. Aspirin can be prescribed with similar safety and benefit. The recent randomized, controlled trials, the 2019 ACC/AHA guidelines, and the 2016 USPSTF recommendations do not dispute the effectiveness of aspirin for the primary prevention of CVD events. They do, however, recognize the risk of major bleeds and recommend clinical judgment when prescribing aspirin to patients so that benefits may be increased and harm reduced. MINNESOTA PHYSICIAN SEPTEMBER 2019
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WEIGHT CONTROL
Bariatric surgery High ROI for severe forms of obesity BY JONATHAN C. GIPSON, MD, FACS
B
ariatric surgery within a multispecialty-supported program represents one of the biggest returns on investment (ROI) that health care providers can achieve today. Not only does weight loss improve the quality of a person’s life, but by preventing or curing life-threatening illnesses, it also can reduce or eliminate the need for medications to treat weight-related comorbid conditions.
disease, and 13 different cancers. People with obesity have seven times the risk of type 2 diabetes and more than double the risk of developing heart failure, according to the American Heart Association.
The National Institutes of Health and the American Society for Metabolic and Bariatric Surgery (ASMBS) recommend considering surgical intervention for Class II patients with medical complications and all Class III patients. Despite the fact that the ASMBS estimates fewer than 1% of the 24 million U.S. adults who may qualify for Worldwide obesity rates continue to increase. bariatric surgery have the procedure each year, the Worldwide obesity rates While lower than the national average of 40%, continue to increase. number of operations has dramatically increased obesity rates in Minnesota of 30% are rising, over the past two decades, from 10,000 weightaccording to the Minnesota Department of Health. loss cases reported in the United States in 1996 to Obesity was officially classified as a medical 235,000 cases in 2018. This growth is largely due disease in 2013, with Class I defined as having a to an increase in obesity rates and greater patient body mass index (BMI) of 30 or higher, Class II as recognition of common threads between obesity and comorbidities. a BMI of 35–40, and Class III as a BMI of 40 or more. The more severe forms of obesity are associated with increased risk of weight-related comorbidities, Preparing a patient for bariatric surgery such as heart disease, hypertension, diabetes, gastroesophageal reflux The best time to discuss weight loss surgery with a patient is during a disease, depression, obstructive sleep apnea, stroke, degenerative joint conversation about intervention to lessen or eliminate an associated medical condition, especially for Class II or III patients. For most people who need to lose 75 or more pounds, the ability to do so and keep the weight off permanently without anatomical support is nearly zero, even with coaching, medicine, trainers, and psychological support.
Solutions through experience and collaboration
Patients involved in multidisciplinary bariatric programs are more likely to achieve and maintain their weight and health goals. All of my bariatric surgery patients undergo a three-to-six-month in-person and online education and screening process, a comprehensive review of their medical history and patientspecific screenings, such as colonoscopy, upper endoscopy, or mammogram. Patients with obesity are less likely to seek screening or routine health visits to avoid the feeling of shame that can come with these appointments. They also meet with our program manager to discuss healthy habits, including diet and exercise, and they consult with a pharmacist to manage their medications. If patients smoke, they need to stop several months prior to surgery. Nicotine induces vasospasm and decreases oxygen delivery to end vessels, hindering bowel anastomosis and wound healing after an operation. Wound infection is five times higher for smokers, the rate of ulcers after stomach surgery is higher, and staple line or anastomosis leak rates are higher.
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All of our patients also undergo psychological evaluations, and introspection is encouraged. The development and maintenance of a good support system among family and friends is critical, as depression and anxiety are common among this population.
Current bariatric surgery options Today, there are several options for bariatric surgery. We use shared decision making when choosing an operation, taking into consideration a person’s eating habits and medical history. Options include:
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SEPTEMBER 2019 MINNESOTA PHYSICIAN
• Sleeve gastrectomy is the most common bariatric surgery in the United States, representing 60% of all weight-loss surgeries. With this procedure, the stomach is divided and stapled vertically, removing approximately 85% of the tissue and leaving a smaller, banana-shaped pouch. Patients with significant reflux should avoid this option, as it can exacerbate heartburn.
as a weight management option prior to orthopedic surgery on weightbearing joints.
Following bariatric surgery, most patients experience an improved quality of life and a greater ability to perform daily activities. Studies reported in the New England Journal of Medicine also reveal bariatric surgery reduces a patient’s risk of premature death by 30%. Specifically, deaths from obesity-related diabetes decrease by 92%, coronary artery disease by 59%, and cancer by Bariatric surgery reduces a 60%, with the greatest reduction in breast and patient’s risk of premature colon cancers.
• R oux-en-Y gastric bypass represents 18% of U.S. weight-loss surgeries. Here, we reduce the stomach to the size of a shot glass and attach it to the middle of death by 30%. the small intestine, bypassing several feet While all surgeries carry risks, bariatric of intestine. At Specialists in General surgery carries a few unique risks, such as leaks Surgery, 100% of bypass patients control in the gastrointestinal system and dehydration. their diabetes with less medication Longer-term risks include a 12% to 15% risk of or even stop all diabetes medications bowel obstruction and as much as a 30% risk of entirely, compared to a national average of 85% who achieve developing symptomatic gallstones. Patients also may experience dumping such control. Roux-en-Y also cures reflux nearly 100% of the syndrome—in which food and sugar move too quickly from the stomach time. This surgery may not be a good option for patients with into the small bowel—causing diarrhea, nausea, or vomiting, more likely alcohol overuse or abuse history, as the smaller stomach pouch with the Roux-en-Y procedure. This, however, is less likely if the patient enables alcohol to pass quickly to the small intestine and be follows the prescribed diet. In the long term, it is important for patients to absorbed much faster. Our multidisciplinary teams screen for participate in regular weight-bearing exercises and take daily vitamin D alcohol overuse, and recommend that patients who do have this and calcium supplements to prevent bone loss. procedure refrain from alcohol for one year after surgery. • A djustable gastric banding refers to a silicone band filled with saline wrapped around the upper part of the stomach to restrict food intake. It is performed in fewer than 3% of the surgeries. It is not as robust as the sleeve or Roux-en-Y, and it has the highest reoperation rate. The band can wear out over time and leak, erode through the stomach, slip out of place, or cause bowel obstructions.
Bariatric surgery to page 204
• Biliopancreatic diversion with duodenal switch permanently removes the majority of the stomach and bypasses as much as three-fourths of the small intestines. It is for patients who need to lose hundreds of pounds. • Intragastric balloons represent a newer procedure involving a saline-filled silicone balloon temporarily placed in the stomach to limit the amount of food that can be eaten. This procedure is only appropriate in patients with much less weight to lose or as a six-month bridge to surgery and is performed in less than 3% of the surgeries. When the balloon is removed, most patients regain the lost weight.
Benefits and risks of bariatric surgery For most patients, the risks of severe obesity outweigh any risks associated with bariatric surgery, and the resolution or improvement in certain conditions following bariatric surgery is significant. According to ASMBS, type 2 diabetes is resolved in 77% of the cases, hypertension is resolved in 62%, obstructive sleep apnea goes away for 84% of patients, and hyperlipidemia is resolved in 62%. Patients also typically realize a reduced risk of cardiovascular disease and cancer, improved fertility and lower-risk pregnancies in women, and a higher chance of having a healthy baby. Bariatric surgery is also performed MINNESOTA PHYSICIAN SEPTEMBER 2019
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3Bariatric surgery from page 19
Value of multidisciplinary approach
Patients considering bariatric surgery should look for surgeons at Growth of robotic bariatric surgery facilities that have been accredited by the ASMBS, have excellent Today, 90% of my bariatric surgeries are performed robotically. Robotic bariatric outcomes, and offer a multidisciplinary approach to care. At Specialists surgery is especially useful for deeper or taller patients, in General Surgery, our team can include revisional bariatric operations, or with patients who the primary care provider, bariatric program have had previous abdominal procedures. nurse manager, surgeon, nurse practitioner, dietician, psychologist, sleep medicine provider, Instruments used in robotic surgery are longer pharmacist, athletic trainer, and home visits and stronger than those used in laparoscopic For most patients, the risks of with someone from North Memorial Health’s cases and have better reach. The two-lens severe obesity outweigh any risks Community Paramedic Program. camera enables accurate 3D imaging, resulting
associated with bariatric surgery.
in improved visibility. When I dissect the gastric pouch or perform a gastrojejunal anastomosis deep in the upper abdomen, I can see better and have more instrument maneuverability compared to the laparoscopic approach. I believe the robotic Roux-en-Y is as good as or better than a laparoscopic approach, due, in part, to the greater precision and articulation of instruments. Over time, I believe we will continue to see the post-surgical leak rate trend toward zero.
With robotic procedures, patients report less pain and less nausea, leading to faster recoveries and better overall outcomes. Typically, my patients can start drinking liquids as soon as they wake up. It has improved the length of stay for our patients, especially those who have a sleeve gastrectomy. While most stay one night, some patients are able to go home the day of surgery.
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SEPTEMBER 2019 MINNESOTA PHYSICIAN
One of the most common reasons for seeking medical help in the first 30 days after surgery is dehydration. That’s why we arrange for a paramedic to visit within 48 hours of discharge, reducing unscheduled clinic and emergency
department visits. Statistics show better overall results with frequent interactions, especially in the year following surgery. We schedule a clinic visit at one week, another paramedic visit at two weeks, a second clinic visit at one month, and a visit with the dietician around five weeks after surgery, around the time a patient starts to eat solid food. Additional visits occur at three, six, nine, 12, 18, and 24 months, followed by yearly visits for life.
Bariatric surgery as a return on investment In the current cost-conscious health care environment, it is not just surgical risk and health reward that we need to consider. We also need to study the financial costs and benefits to the surgical treatment of obesity. A significant number of patients resist bariatric surgery because of insurance denials or prerequisites. The average national cost of bariatric surgery is between $17,000 and $26,000, according to ASMBS. Yet, bariatric surgery provides a significant ROI. We can prevent or cure life-threatening illnesses in our patients, many of whom say the surgery is transformative, especially in regard to quality of life. Unhealthy dietary and lifestyle behaviors are addressed early, and healthy changes are supported at subsequent visits. Medications are often reduced or eliminated. The Centers for Disease Control and Prevention reports the medical cost of obesity in the United States to be $147 billion. Within five years of bariatric surgery, however, the average health care cost for patients is reduced by 29%. In addition, after surgical treatment of severe obesity, an individual’s work productivity increases $2,765 per year in the United States. As insurance companies begin to recognize this ROI, more and more are covering bariatric surgeries, resulting in improved total cost of care for this health population—and improved quality of life for patients diagnosed with obesity. Jonathan C. Gipson, MD, FACS, is a surgeon with Specialists in General Surgery. He also is Medical Director of Metabolic and Bariatric Surgery at North Memorial Health Hospital, which partners with Specialists in General Surgery to provide comprehensive care, management, and planning for surgical weight loss in qualified patients.
3Aspirin for primary prevention from page 17 • Patient’s preference to avert a heart attack or stroke vs. to risk a GI bleed (patient’s evaluation of benefit vs. harm)
How about my patients already using aspirin for primary prevention? Fewer research studies have addressed this question, yet a recent study in Sweden found that aspirin discontinuation led to increased CVD events among over 600,000 adults using aspirin for primary or secondary prevention (Sundstrom J et al., Circ 2017;136(13):1183-1192). When adults using aspirin for primary prevention were examined, aspirin discontinuation led to a 28% higher rate of CVD events when compared to those with aspirin continuation. Notably, the mean age in this study was 73 years old, above the recommended age cutoff identified in recent studies. The benefit of aspirin was consistent in subgroup analysis of patients <70 and ≥70 years. This finding suggests that patients who start aspirin—and tolerate it without a major bleeding event— may benefit from continuation even into older age.
What resources are available? The Minnesota Heart Health Program (MHHP) at the University of Minnesota received NIH funding to study the effectiveness of a statewide intervention to increase appropriate primary prevention aspirin use. Efforts are made to increase public and provider awareness of the appropriate indications for aspirin use. Community efforts included social media-based education as well as traditional media outlets. There is also a clinical intervention seeking to develop quality improvement efforts around identifying primary prevention aspirin candidates. To support these efforts, MHHP has developed a toolkit of resources for clinics and physicians that includes a risk calculator, electronic and printed educational materials, brochures, and infographics regarding aspirin use. These materials can be found at www.askaboutaspirin.umn.edu under the partner toolkit and the calculator at www.askaboutaspirin.umn.edu/calculator. It is our goal to facilitate the use of aspirin to reduce first CVD events when appropriate and to help avoid use in those with elevated bleeding risk. Russell V. Luepker, MD, MS, is Mayo Professor of Public Health at the
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MINNESOTA PHYSICIAN SEPTEMBER 2019
21
PEDIATRICS
Recognizing childhood and adolescent hypertension A new clinical decision support tool BY ELYSE KHARBANDA, MD, MPH, AND HEIDI EKSTROM, MA
S
tarting at age three and continuing through adolescence, at least once per year it is recommended that children and adolescents have their blood pressure measured during a primary care visit. For those at increased risk for hypertension, based on family history, obesity, or presence of other medical conditions, blood pressure should be measured at every clinical encounter. Updated definitions for hypertension in this age group have recently been published. In children 3–12 years of age, hypertension is defined as having blood pressure at or above the 95th percentile, based on their age, sex, and height at three separate clinical encounters. Mild elevations in blood pressure, at or above the 95th percentile, are classified as stage 1 hypertension, while blood pressures at or above the 95th percentile + 12 mmHG or above 140/90 mm Hg are classified as stage 2 hypertension. For adolescents 13–17 years of age, hypertension is defined as having blood pressure at or above 130/80 mm Hg at three separate visits and stage 2 hypertension is based on having blood pressures at or above 140/90 mm Hg at three separate visits. It is estimated that 1–3 percent of children and adolescents meet clinical criteria for hypertension, with a majority classified as stage 1.
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Hypertension (HT) during childhood or adolescence is generally asymptomatic. Rarely, new hypertension in an older child or adolescent may be a sign of an underlying cardiac, renal, or endocrine disorder. However, for the most part, mild or stage 1 hypertension presenting in youth is idiopathic, also known as essential hypertension. Recognition is important as hypertension in adolescents has been found to be associated with increased stiffness of blood vessels and hypertrophy or thickening of the heart. Long-term risks associated with pediatric or adolescent hypertension include the persistence of hypertension into adulthood, along with future cardiovascular morbidity and mortality. The initial management of hypertension in children or adolescents is generally through lifestyle modifications, diet, and exercise. Antihypertensive medications may be considered if lifestyle changes are not effective, in cases where there is evidence of cardiac hypertrophy or other target organ damage, or when blood pressures are very elevated, consistent with stage 2 hypertension.
Barriers to hypertension recognition In more than half of pediatric and adolescent patients with evidence of hypertension, based on blood pressures recorded at three or more primary care visits, their hypertension is not diagnosed or otherwise clinically recognized. Barriers to recognizing or diagnosing hypertension are numerous and include perceived complexities of the current hypertension definitions, which vary by age, and the need to review both current and previous blood pressure measurements to diagnose hypertension. For most pediatric and adolescent patients with an elevated blood pressure measurement, screening for hypertension is not the reason for their visit. With numerous competing demands or more urgent needs to attend to during the visit, providers may be challenged to find time to remeasure or further evaluate the blood pressure, especially when patients are seeking care for other health concerns. In addition, some providers may not be aware of or in agreement with the updated pediatric and adolescent hypertension guidelines. As a final barrier, the provider’s behavior in response to an elevated blood pressure may be reinforced by his or her clinical experience. It is common for a single blood pressure measured in a pediatric primary care setting to be elevated—patients may be anxious about the visit, in pain, or there could be errors in measurement procedures leading to falsely elevated readings. Usually, when remeasured during the same visit, or at a subsequent visit, the next blood pressure will be normal. Thus, for most children and adolescents, when an elevated blood pressure is not clinically recognized, there is no immediate harm. Nevertheless, in a subset of patients, an elevated blood pressure recorded during a primary care visit is the first sign that the child or adolescent has developed hypertension. This is where health care organizations can leverage technology, by way of decision support that goes beyond simple prompts and reminders, to map trends over time and notify providers of these trends at the right time in the visit.
About the Peds & TeenBP Clinical Decision Support tool The goals of our project were to improve recognition of elevated BP and
hypertension, and to promote next steps in care consistent with pediatric intervention period met clinical criteria for hypertension. Within six months of hypertension guidelines. We aimed to achieve these goals targeting pediatric meeting criteria for new onset hypertension, 55 percent of Peds & TeenBP CDS and adolescent patients presenting for primary care visits, integrating patients versus 21 percent of patients at usual care clinics were recognized as relevant clinical data within their electronic health record with clinical having elevated blood pressure or hypertension (p<0.001). The most common decision support (CDS) to provide tailored, form of recognition was having hypertension or patient-specific recommendations for nursing elevated blood pressure as a discharge diagnosis staff and medical providers. The Peds & TeenBP at an outpatient encounter, documented in a CDS was developed based on published guidelines clinical note, or described in the patient discharge and adapted for use within HealthPartners based instructions. Only 10 percent of patients at Peds & Updated definitions for on detailed evaluation of clinical workflow and TeenBP CDS clinics and 5 percent of patients at the hypertension in this age group input from leaders in pediatrics, family medicine, usual care sites had hypertension or elevated blood have recently been published. nursing, and informatics. Our goal was to design, pressure added to their problem list. develop, and implement CDS consistent with Evaluations for secondary causes of best practices, containing the right information, hypertension or target organ damage were delivered to the right person, through the right uncommon overall, but were more common in channel, and at the right time during the clinical patients attending Peds & TeenBP intervention encounter to ensure use. versus usual care clinics (9 percent versus 4 percent, p=.046). Of note, The Peds & TeenBP CDS incorporates prompts and reminders but also includes the following innovative features: 1. The CDS uses a web-based application linked to the EHR, which runs algorithms that determine if a patient meets hypertensive criteria based on national guidelines. 2. It provides an intuitive interface that graphically represents BP percentile range and variation over time. The tool takes into account patient age, current and prior blood pressures, current body mass index, medications, and diagnoses, and provides tailored recommendations regarding diagnoses and next steps in care. The interface can be printed for families, facilitating shared decision making regarding next steps in care.
none of these patients undergoing additional work-up had a secondary cause for hypertension identified. Referrals to a dietitian, weight loss, or exercise program were also more common in patients at a Peds & TeenBP CDS intervention clinic (17 percent) versus patients at a usual care clinic (4 percent) (p=.001). Provision of antihypertensive medication within six months of meeting criteria occurred in <1 percent of patients overall and did not differ between intervention and usual care clinics. Recognizing childhood and adolescent hypertension to page 284
3. The web-based structure of the CDS allows for simplifying clinical updates over time and enhancing the translatability of the CDS to other EHR systems. In order to understand its impact on care, starting in April 2014 we implemented the Peds & TeenBP CDS in 10 primary care clinics serving children and adolescents 10–17 years of age within HealthPartners Medical Group. We conducted in-person trainings at each of the 10 clinical sites at the beginning of the project to orient nurses and providers to the tool and to answer questions and gather feedback. Refresher training was conducted one year later to provide sites with use results and impact of the tool on the specific clinic as well as a general reminder of the what and why of the project to seasoned staff and to new staff. In addition, feedback regarding use of the CDS reports over the two-year project period was provided to leads at the Peds & TeenBP intervention clinics in the form of monthly use rates. The remaining comparison clinics did not have access to the Peds & TeenBP CDS and instead follow usual care. Among patients meeting clinical criteria for hypertension, our primary outcome was clinical recognition of hypertension. In addition, we evaluated specific next steps in care including lifestyle counseling, dietitian referrals, and additional diagnostic evaluations. Consistent with prior studies, hypertension was uncommon in our population. Only 1.5 percent of youth 10–17 years of age with at least one blood pressure recorded in their electronic health record over the two-year
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Volume XXXII, No. 05
CAR T-cell therapy Modifying cells to fight cancer BY VERONIKA BACHANOVA, MD, PHD
U
niversity of Minnesota Health is now among the few selected centers in the nation to offer two new immunotherapy drugs for the treatment of diffuse large B-cell lymphoma. Both drugs—Yescarta and Kymriah—are part of an emerging class of treatments, called CAR T-cell therapies, that harness the power of a patient’s own immune system to eliminate cancer cells.
Physician/employer direct contracting
CAR T-cell therapy involves drawing blood from patients and separating out the T cells. Using a disarmed virus, the patient’s own T cells are genetically engineered to produce chimeric antigen receptors, or CARs, that allow them to recognize and attach to a specific protein, or antigen, on tumor cells. This process takes place in a laboratory and takes about 14 days. After receiving the modification, the engineered CAR-T cells are infused into the patient, where they recognize and attack cancer cells. Kymriah received initial FDA approval in 2017 for the treatment of pediatric acute lymphoblastic leukemia. CAR T-cell therapy to page 144
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ith the continuing escalation of health care costs, large and midsized selfinsured employers are once again looking for an edge to manage their medical plan costs and their bottom line. They understand that they are ultimately funding health care as they pay for their population’s claims.
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Many of these employers have employed the same overarching set of strategies: shop for a new carrier that is willing to lower the administrative costs or underprice the risk, Physician/employer direct contracting to page 124
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ADMINISTRATION
Posting the cost of health care Complicated compliance issues BY NANCY F. NELSON, FSA, MAAA
M
innesota providers should review their practices now to ensure compliance with new pricing transparency requirements that took effect on July 1, 2019. The Minnesota Legislature approved amendments to Minnesota Statutes 62J.81 in the 2018 legislative session; Gov. Mark Dayton signed the bill on May 19, 2018. The law also adds new transparency requirements for health insurance companies.
Requirements prior to the new bill Health care providers had been required to provide information about payments at the request of a consumer, and at no cost to the consumer. “Provider” was broadly defined to include persons or organizations providing health care or medical care services for a fee, but excluded nursing homes. The prior requirement was to provide a good faith estimate of the amount the provider had negotiated as payment from the consumer’s health plan for any services specified by the consumer. If the consumer had no health plan, the provider was to provide a good faith estimate of the average payment
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the provider would accept from private third parties for the services, and the estimated amount the consumer would be required to pay. Health plans were subject to a similar disclosure requirement. They were to provide an enrollee (i.e., the consumer member of the health plan) with a good faith estimate of the amount the health plan had contracted for with a specific provider in the plan’s network as total payment for the specified service. The health plan was further required to estimate what portion the member would be required to pay of the total, effectively requiring the health plan to make a prospective application of the member’s expected insurance benefits such as copayments, deductibles, and coinsurance. However, the estimate was not binding on the health plan.
New requirements The amendments to the bill expand prior transparency requirements significantly. All providers are now required to provide information on other fees or charges that the consumer is likely to incur in conjunction with a visit, including any related facility fees. Additional disclosure requirements applicable only to primary care providers include the top 25 most commonly billed procedures. These are to be identified as the most frequently billed current procedural terminology (CPT) codes, including the 10 most common evaluation and management (E&M) codes, and the 10 most frequently billed codes for preventive services. If a provider is part of a health care system, the list may be developed using the mix of services provided across the system. Primary care providers are defined to include a provider or clinic specializing in family medicine, general internal medicine, gynecology, or general pediatrics. For the 25 top CPT codes, several different amounts must be disclosed, including: • The provider’s charge. • The average reimbursement received from commercial health plans. • The Medicare allowable payment rate. • The Medical Assistance Fee-For-Service Payment rate. The provider’s charge is defined as the amount that must be paid by a consumer with no public or private insurance. This information on the top 25 services must be made available on the provider’s website, and be posted in the reception area of the office or clinic. Timing requirements are now specified, and apply to both providers and health plans. Once a complete request for information is received by either a provider or health plan, the information must be provided to the consumer or enrollee within 10 business days.
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The final change clarifies that the transparency requirement may not be avoided through the application of any contractual language between a provider and a health plan company.
Providing price information to a consumer isn’t so easy Providing patients with information about expected prices is a laudable goal. It is valuable to a consumer as a tool for decision making on elective procedures, for managing benefits under high-deductible plans, and potentially for comparing one provider to another. However, while data on prices and consumer experience may be generalized, each patient will have an individual experience that may be significantly different from a “typical” experience. For example, a colonoscopy is a common procedure. For a typical case, expenses might include the CPT code for the procedure, a facility charge, and fees for anesthesia. With normal results, these would all be typically paid by the health plan as preventive services and the enrollee would likely incur no out-of-pocket expense.
develop from a broad range of factors. Examples include an unexpected need for screening tests for the fetus, delivery by caesarean section, pre-term delivery, identification of multiples, need for anesthesia, complications from infections, etc. The list of variables is very long even for this very common condition.
The amendments to the bill expand current transparency requirements significantly.
These examples help show how different a patient’s costs might be relative to an expected average. Communicating assumptions used to develop an expected cost provided to members will be extremely important; the “small print” type of footnotes will be very important to help make it clear to patients that the good faith estimate is truly only an estimate, and that each procedure may entail additional unexpected costs.
Developing an approach to respond to requests for best estimates
However, if even the smallest polyp is found and removed, the procedure is no longer preventive. The consumer in this situation would likely be facing a higher bill for a CPT code reflecting the more complex procedure, plus additional fees for lab services to test the sample. And, because the service is no longer preventive, the consumer might be facing a very large out-of-pocket expense.
To provide a best estimate of costs, a provider needs to be ready to identify both the fees for services they will provide as well as the services and fees that the consumer may receive from other providers or facilities. A structured approach to identify these components’ affected price will be needed. While providers will have information about their own practices, they will not necessarily be privy to the expected costs for a hospital
Costs for maternity care can also vary broadly. Many complications relative to the desired normal delivery at 40 weeks are possible. Variations in cost could
Posting the cost of health care to page 264
V Alzheimer’s is now an approved condition V
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MINNESOTA PHYSICIAN SEPTEMBER 2019
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3Posting the cost of health care from page 25
Pharmacy Benefits Manager (PBM), or between a self-funded employer and a PBM.
admission, outpatient facility services, outpatient drugs, or therapies. For providers working in an integrated system, this information will likely be more available, and ideally provided in some centralized way to the staff who must complete the good faith estimates.
If providers take care in developing the list of related fees and charges that are likely to be associated with a particular service, the educational benefit to consumers will be significant. Consumers will be in a better position to understand all the requirements of care before and after a health care procedure.
For health care providers working more independently, a process to obtain cost estimates for hospital admissions and average outpatient facility charges at the facilities where the provider typically performs procedures will be needed. These estimates will likely need to be less specific than those for services provided at the provider’s own office or clinic.
Information on the top 25 services must be made available.
The requirement that the estimate be specific to the payments that are expected for the consumer’s specific health plan is likely problematic. While the law makes it clear that contracts cannot impede release of information to a consumer, it does not require one type of provider to share information with another. Similarly, expected costs for prescription drugs are likely to be of much interest to patients and valued if available, but highly problematic for both independent providers and for those in integrated systems, since drug costs are likely subject to contracts between a health plan and a
The fact that a consumer may request an estimate from both their health plan and their provider may create some challenges for both. The health plan is likely in a better position to access and summarize data related to all the expenses associated with a particular service.
If this information is presented in a different format, or in a significantly different level of detail, or with a materially different estimate of costs, consumers may become frustrated. Consumers are likely to demand time from providers to discuss the expected costs and mix of related services.
Developing an approach for reporting the top 25 primary care services Identifying the top 25 procedure codes for primary care provider practices should be a more straightforward analytical exercise. Data on charges by CPT code for the practice could be summarized for a recent calendar period (e.g., a recent 12-month period) and sorted by code and volume of
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SEPTEMBER 2019 MINNESOTA PHYSICIAN
procedures. The top 10 E&M codes and the top 10 preventive codes could be selected from this ranked list, and the next five additional CPT codes selected based on volume.
Providers should review their practices now to ensure compliance. In many cases, the provider’s own data will not be sufficient to respond to provide a best estimate of costs.
This data could then be further sorted by payor category to develop the required averages for payments by commercial insurance plans, Medicare, and the Minnesota Medical Assistance (Medicaid) fee-for-service program. Charges should be readily available, since they are established by the provider. If data on payments by the Centers for Medicare & Medicaid Services (CMS) or by Minnesota Medical Assistance is not of sufficient volume to determine average payments, methods to determine them are publicly available through CMS and the Minnesota Department of Human Services (DHS).
Providers and health plans must also consider what new processes are needed to manage the flow of requests for the cost estimates; a timely response to a complete request must be provided in no more than 10 business days.
In developing the list of averages, the primary care providers would wish to consider the optimal time of year to develop the lists, and how frequently they should be updated. If health plan contract renewals and charge master changes generally occur each January, it may be desirable to create the initial list in the fourth quarter of the year and then finalize it to reflect contract changes each January.
encounter data.
Nancy F. Nelson, FSA, MAAA, is a Principal at Cirdan Health Systems Consulting in St. Paul. Cirdan provides actuarial and data consulting services to health plan and provider clients, including extensive work with claim and
Analytical resources to support compliance The data expertise and resources needed to create the process to prepare estimates and the analysis of average costs for the top 25 services may be in-house for large integrated provider systems. Alternatively, consultants with expertise in analysis of medical claim and encounter data could provide the needed support to help ensure a provider practice is ready with the required tools and information to ensure compliance under the new law.
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Additional transparency requirements may be added by CMS The need to support consumers by making cost information—including expected out-of-pocket amounts—available is also recognized by CMS. On July 12, 2018, CMS announced release of a Request for Information (RFI) seeking comments regarding “whether providers can and should be required to inform patients about charge and payment information for health care services and out-of-pocket costs, what data elements would be most useful to promote price shopping, and what other changes are needed to empower healthcare consumers.” The RFI may be found at www. federalregister.gov with a search for July 12, 2018, or Agency/Docket Number CMS-1678-P. Specific concerns identified by CMS regarding price transparency include “surprise” bills for services provided by a non-network provider at an in-network facility and bills for services that are part of an episode of care but not part of a hospital stay, such as home health or therapy services.
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Summary Minnesota providers and health plan companies face steep new requirements regarding price transparency under the new law. Both must be prepared to offer best estimates of not only the cost of a specific service, but also of any charges and fees for related services that might be incurred as a result of the service for which the estimate is requested. Health plan companies are further burdened to provide an estimate of the portion of the fee that a member will pay. Primary care providers must further be prepared to publish information about their charges, and average commercial, Medicare, and Medicaid fee-for-service reimbursement of a list of the top 25 services they provide, with an emphasis on E&M codes and preventive codes.
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3Recognizing childhood and adolescent hypertension from page 23
departments. Although our formal research study has ended, we plan to continue to evaluate the impact of Peds and TeenBP CDS, now integrated as part of routine care. In addition, we plan to further promote cardiovascular health for children and adolescents through the dissemination of the Peds & TeenBP decision support tool in additional health systems in the region.
Among 86 primary care providers at Peds & TeenBP intervention clinics, 71 (83 percent) completed a brief survey between March and June 2016. Eighty percent of respondents were physicians and 20 percent were advanced practice providers; 65 percent had over 10 years of experience in clinical practice. A majority of respondents (75 percent) recalled interacting with the Peds & TeenBP CDS. Barriers to recognizing Of those who reported using the CDS, 92 percent or diagnosing hypertension thought it was useful in identifying patients with are numerous. elevated BP or hypertension, 94 percent agreed that time using the Peds & TeenBP was “time well-spent,” and 95 percent agreed that Peds & TeenBP was useful for shared decision making.
Elyse Kharbanda, MD MPH, is a senior research investigator and pediatrician at HealthPartners Institute. She is the principal investigator or co-investigator on several NIH- and CDC-funded studies covering a range of topics in maternal and child health, including two studies of clinical decision support for improving health outcomes in children and adolescents. The project described in
Outcomes The Peds & TeenBP CDS tool, developed and implemented in this study, significantly increased recognition of incident hypertension, promoted next steps in care consistent with pediatric hypertension guidelines, and was well accepted by the providers. Nevertheless, further work is needed to continue to increase hypertension recognition and to promote adoption of a healthy lifestyle in this population at risk for long-term cardiovascular morbidity. The Peds & TeenBP CDS has now been implemented system-wide across HealthPartners outpatient settings where blood pressure is routinely measured, including primary care, pediatric endocrine, and pediatric behavioral health
this article was supported by the National Institutes of Health (R01 HL115082).
Heidi Ekstrom, MA, is a principal project manager for Clinical Decision Support Applications at HealthPartners Institute. She is responsible for coordinating the development, implementation, and maintenance of several projects designed to test the effectiveness of sophisticated clinical decision support tools.
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Minimize the things that get in the way of why you’re in healthcare to begin with. A focus on reducing lawsuits is just one way we do this. For more information or your nearest agent, contact us at 800.225.6168 or through coverys.com. M E D I C A L P R O F E S S I O N A L L I A B I L I T Y I N S U R A N C E A N A LY T I C S R I S K M A N A G E M E N T E D U C A T I O N
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3Insulin pricing from page 15 transparency requirements regarding manufacturer rebate trails, PBM strategies utilizing aggressive “spread pricing” and “clawbacking” tools to increase retail costs and copays in an attempt to increase revenues, and the ability of employers and insurance companies to view more financial data from PBM activities. Despite the passage of a biennial budget, many other important initiatives fell by the wayside. One of these was the insulin bill chief-authored by Senator Melissa Wiklund (DFL) and co-authored by me. This bill had several components, one of which was authorization for emergency prescription refills of insulin in situations when a current prescription was not available—this feature was added onto the Health and Human Services omnibus bill, which passed in the special session. However, the actual insulin assistance program clause—the heart of the Alec Smith bill, named for a Minneapolis man who died because he could not afford his insulin—did not get a hearing in the Senate, nor did it get tacked on to any other bills. During a truncated and chaotic endof-session discussion of numerous insulin proposals—two Republican and two Democratic submissions—no insulin initiatives were allowed to be vetted in the customary manner, and nothing passed in the House or Senate. In the special session, the tribunal of leaders decreed there would be no amendments allowed on any of the omnibus bills and that the session had to adjourn by 7 a.m. on May 25. This edict essentially killed the possibility of enacting any insulin assistance program legislation. In early June a bipartisan, bicameral group of legislators came together to remedy the legislative shortcoming regarding an insulin assistance
program and hammered out details establishing applicant eligibility criteria, a network of participating pharmacies, and possible sustainable sources of funding. Today only the funding issue remains a point of contention and this question cannot be resolved without Gov. Tim Walz, Sen. Paul Gazelka (R), and Rep. Melissa Hortman (DFL) coming together, rolling up their sleeves, and putting forth a joint proposal. The puzzling aspect for me regarding the development of an insulin assistance program is this: if both parties care deeply about people with pre-existing conditions, why don’t the leaders in the House and Senate commit to getting a program in place? Arguably, there is no more prevalent and galvanizing chronic disease than diabetes. When diabetes care involves insulin with its punishingly inflated prices, lives become threatened. The time is now. Minnesota can lead as we have led before. A basic package of health care services for all Minnesotans is not too much to ask. Sharing the burden of pre-existing conditions and the cost associated with chronic medical problems is not too much to ask. And finally doing something now rather than later to create an insulin assistance program is not too much to ask. And, in fact, Minnesotans are asking.
Scott Jensen, MD, is a family physician practicing in Watertown and Chaska, Minnesota. He is an associate professor at the University of Minnesota Medical School and a state senator (R) serving as vice-chair of the Health and Human Services committee. He was chair of the Senate Select Committee on Health Care Consumer Access and Affordability in 2017 and 2018.
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YOU’D MAKE A REALLY GOOD DOCTOR IF YOU WEREN’T BEING AN OFFICE MANAGER.
Urgent Care Physicians HEAL. TEACH. LEAD.
At HealthPartners, we are focused on health as it could be, affordability as it must be, and relationships built on trust. Recognized once again in Minnesota Physician Publishing’s 100 Influential Health Care Leaders, we are proud of our extraordinary physicians and their contribution to the care and service of the people of the Minneapolis/St. Paul area and beyond. As an Urgent Care Physician with HealthPartners, you’ll enjoy: • Being part of a large, integrated organization that includes many specialties; if you have a question, simply pick up the phone and speak directly with a specialty physician • Flexibility to suit your lifestyle that includes expanded day and evening hours, full day options providing more hours for FTE and less days on service • An updated competitive salary and benefits package, including paid malpractice HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. Find an exciting, rewarding practice to complement all the passions in your life. Apply online at healthpartners.com/careers or contact Maly at 952-883-5425 or maly.p.yang@healthpartners.com. EOE
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3A changing role of pharmacy from page 13
out and having the opportunity to share what pharmacists can do to assist in caring for patients as a part of the health care team. The reason for this is that pharmacists often have little time to present on the benefits of utilizing a pharmacist to clinicians and, additionally, often are communicating via phone or fax with nurses rather than directly with clinicians. Another barrier is not having access to the electronic medical record (EMR), especially for community pharmacists who could assist with ensuring that the patient’s therapy is effective and safe. Even having read-access only to the EMR allows pharmacists to provide better care. There are examples across the country (North Carolina and Iowa) who have read-only access or access to the EMR to write notes for clinicians. I encourage health systems and clinicians to reach out to local pharmacies to see how their local pharmacist could assist.
their higher levels of services to patients in the outpatient setting. These services may include chronic care management, immunizations, medication delivery, medication administration, and more. Minnesota is in the process of building its own CPESN.
Pharmacists’ Patient Care Process The process of pharmacist care is guided through the Joint Commission of Pharmacy Practitioners (JCPP). To ensure consistency in any practice setting where pharmacists provide patient care, the JCPP developed the Pharmacists’ Patient Care Process. Steps in that process, in order, call for pharmacists to: • Collect
By incorporating the pharmacist on your care team, you will free up more time to care for your complicated patients. Reach out to your local pharmacists and discuss what opportunities exist for you to work as a team. In addition, encourage your patients to talk to their local pharmacist and better understand their services and how they can assist the patient.
• Assess • Plan • Implement • Follow Up: Monitor and Evaluate At the center of this process is the patient, as well as collaboration, communication, and documentation. Each step is vital to pharmacistprovided patient care. Learn more at https://jcpp.net/patient-care-process/.
Sarah Derr, PharmD, currently serves as the Executive Director at the Minnesota Pharmacists Association. Dr. Derr completed her residency in
Moving forward
ambulatory care at Fairview Health Services, then served as the inaugural
Communication is the biggest barrier for pharmacists to collaborate with other health care professionals. One communication challenge is reaching
executive fellow at the Iowa Pharmacy Association and the Medication Management Pharmacist for the Iowa Healthcare Collaborative.
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3Understanding regenerative medicine from page 11
Unfortunately, these regenerative medicine treatments remain outside of the covered benefits for Medicare and for most private insurers. One reason for this is the lack of standardization in both the research base and in clinical practice, with regenerative medicine preparation protocols varying widely and few providers qualified to use both ultrasound and fluoroscopic guidance.
$30k–$50k joint replacement. This, of course, requires physicians to be stewards of the resources and only treat patients who are medically appropriate. We have found that about 70% of elective orthopedic surgeries can be avoided by first treating with regenerative medicine, while some findings like severe hip arthritis or myelomalacia are still best treated with surgery. To date, over 30 self-funded employers representing 6 million covered lives have decided to cover Regenexx procedures. This has the added benefit of getting workers back to full duty more quickly—typically in just 3 to 21 days following a regenerative procedure— versus much greater lost productivity following a more invasive procedure. As private insurers see more and more claims for joint replacements and spinal fusions in younger workers, they may also decide to reconsider regenerative therapies as a first-line option after rest and physical therapy.
Another barrier, particularly in the Medicare setting, is concern that high utilization in mild-to-moderate cases could offset the cost savings relative to a surgery that is performed on only the most severe cases. In that scenario, performing a high volume of corticosteroid injections with a low volume of invasive surgeries remains the cost-effective option. Yet orthopedic injuries continue to be the number one cause of missed work, and orthopedic treatments continue to be the number one expense in most companies’ health plans. Nearly one third of all health care expenditure is on orthopedics, representing $510 billion dollars or 5% of the GDP, and those costs continue to rise.
Both patients and physicians are looking for a treatment that can treat the root cause of pain rather than relying on opiates or steroids to mask it. In the right patients, regenerative medicine fulfills that promise. Conditions that previously required major surgery are now being effectively treated with orthobiologic injections and minimal downtime. While more studies will help clarify the best protocols and the best prospective patients, the future is now with regards to regenerative medicine. As interventional orthopedics becomes more organized and professionalized, expect to see it enter the mainstream, with or without insurance coverage.
impossible to blind a patient to a bone marrow harvest, and unethical to discard their cells and instead randomize them to a placebo. What we do have is a large base of prospective evidence demonstrating safety, with longterm satisfaction scores that are superior to the standards of care, even in patients with severe or chronic injuries.
As a result, many of the self-insured companies that finance their own health plans have taken a second look at the data for nonsurgical regenerative therapies. Our outcome data supports the financial viability of providing $2k–$6k Regenexx procedures as a covered benefit in order to reduce the demand for a
Nate Crider, MD, FAAPMR, is a physiatrist who has been practicing regenerative medicine full-time with Regenexx since 2016 and is now seeing patients in the Regenexx at Nura clinic, located in Edina.
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is for kidney transplants.
Surgical innovation and experience University of Minnesota Health is leading efforts to expand the number of organs available to kidney transplant patients, including the opportunity to participate in a national kidney paired exchange program allowing donors who are incompatible with their recipient to provide the gift of transplant. Just one of the many reasons referring providers and patients alike choose University of Minnesota Health.
Read more about our program at: MHealth.org/kidneytransplant
University of Minnesota Health is a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. Š2019 University of Minnesota Physicians and University of Minnesota Medical Center